39th Annual Hawaii Dermatology Seminar: Scientific Abstract

Grand Hyatt, Kaua'I, Hawaii

March 1-6, 2015

PA-01: A phase 2 randomized trial of a new minocycline foam for the treatment of moderate-to-severe acne vulgaris

Stein-Gold L,1 Shemer A,2 Sprecher E,3 Shiri Y4
1Henry Ford Health System, Detroit, Michigan, USA.
2Lev-Yasmin Clinic, Netanya, Israel.
3Sourasky Medical Center, Tel Aviv, Israel.
4Clalit Health Services, Tel Aviv, Israel.

BACKGROUND: Oral tetracycline antibiotics are a mainstay in the treatment of moderate-to-severe acne vulgaris (AV), yet are associated with adverse effects. FMX101 is a novel, stable foam formulation of minocycline for the topical treatment of moderate-to-severe AV.
OBJECTIVE: This dose-finding Phase II study sought to determine an effective dose of minocycline foam and to evaluate its efficacy, safety, and tolerability compared to vehicle.
METHODS: A prospective, multi-center, randomized, doubleblind, vehicle-controlled, parallel group study was conducted in which participants who had moderate or severe AV were to receive either FMX101 4%, FMX101 1%, or Vehicle for 12 weeks. Subjects were required to have ≥ 20 but ≤ 50 inflammatory lesions (papules and/or pustules) on the face, ≥ 25 but ≤ 100 noninflammatory lesions and an Investigator’s Global Assessment of disease severity (IGA) score of 3 to 4 (moderateto- severe). Subjects were evaluated after 3, 6, 9 and 12 weeks by counting facial lesions (inflammatory and non-inflammatory) and by the IGA score.
RESULTS: A total of 150 subjects enrolled; 139 were in the mITT analysis having receiving at least some treatment. Subject who received FMX101, 4% had significantly greater reductions in the number and percent of inflammatory, noninflammatory and total facial lesions at 12 weeks. A significant reduction in inflammatory lesions in this group was observed as early as after 3 weeks of treatment. FMX101, 4% also produced significantly greater improvement and more successes (clear or almost clear at 12 weeks) in investigator global assessments of disease severity (IGAThe effects of FMX-101, 1%, in inflammatory and non-inflammatory lesions FMX101 were qualitatively similar to FMX-101, 4%, though smaller; the reduction was statistically significant for inflammatory lesions but not non-inflammatory lesions compared to vehicle. No treatment-associated systemic adverse events were noted. Dermal reactions (erythema, dryness, pigmentation or peeling) were infrequent, mild, transient and occurred equally in the active and vehicle groups.
LIMITATIONS: This Phase 2 study was relatively small. Although the lower dose of FMX101, 1% was not significantly better than placebo, this may be the result of the lower power of a study of this size. The same might be true of the failure to show an effect on non-inflammatory lesions.
CONCLUSION: FMX101. 4% (minocycline foam) is a safe and viable treatment for moderate-to-severe AV and the product’s further development is warranted.
CORRESPONDING AUTHOR: Linda Stein-Gold, MD, Henry Ford Medical Center – New Center One, Department of Dermatology, 3031 West Grand Boulevard, Suite 800, Detroit, MI 48202. E-mail: [email protected].
DISCLOSURES: This study was funded by Foamix Pharmaceuticals. Drs Shemer, Sprecher, and Shiri, served as principle investigators in the study. Dr Stein-Gold served as an advisor for Foamix Pharmaceuticals.

PA-02: A randomized, evaluator-blinded, controlled study of efficacy and safety of a small particle hyaluronic acid plus lidocaine for lip augmentation

Baumann LS,1 Ava T. Shamban AT,2 Cox SE,3 Rueda MJ,4 Nogueira A4
1 Baumann Cosmetic and Research Institute, Miami, Florida, USA.
2 Laser Institute for Derm and European Skin Care, Santa Monica, California, USA.
3Aesthetic Solutions, Raleigh-Durham, North Carolina, USA.
4Galderma Laboratories, LP, Fort Worth, Texas, USA.
BACKGROUND: Hyaluronic acid (HA) fillers are frequently used to enhance lip fullness, sculpt the lips, and restore volume loss that occurs with age. Restylane® (Galderma Laboratories, LP) is a small gel particle hyaluronic acid (SGP-HA) filler indicated for lip augmentation in patients over the age of 21. A new formulation of SGP-HA has been developed that contains smaller HA gel particle sizes plus lidocaine (SPHAL), which may be ideally suited for lip augmentation and for the correction of perioral rhytids in patients over the age of 21.
OBJECTIVE: The objective of this study was to determine the efficacy and safety of a small particle hyaluronic acid plus lidocaine for lip augmentation.
METHODS: A randomized, evaluator-blinded, controlled study was conducted to assess the efficacy and safety of SPHAL for lip augmentation. Men and women between the age of 18 y to 65 y with a Medicis Lip Fullness Scale (MLFS) score of 1 (very thin) or 2 (thin) were eligible for study. Subjects were randomized 3:1 to SPHAL or no treatment. Treatment was administered at baseline with an optional touchup 2 weeks after baseline. Both groups were treated after 24 weeks with an optional touch-up 2 weeks later. The primary efficacy endpoint was treatment success (at least 1 grade improvement in MLFS) 8 weeks after initial treatment.
RESULTS: A total of 221 subjects were enrolled and randomized. SPHAL was significantly better than no treatment at 8 weeks as assessed by the blinded evaluator (76.1% vs 11.6%; P < .001). SPHAL was also significantly better at weeks 12, 16, 20, and 24 compared to no treatment (P < .001). The most common adverse events were contusion, lip swelling, lip pain, pain, lip disorder (bumps), and headache.
LIMITATIONS: External validity may be limited due to strict eligibility criteria.
CONCLUSION: This study demonstrates that SPHAL is an effective and safe treatment for lip augmentation.
CORRESPONDING AUTHOR: Maria-Jose Rueda, MD, Galderma Laboratories, LP, 14501 North Freeway, Fort Worth, TX 76177. E-mail: [email protected].
DISCLOSURES: Drs Baumann, Shamban, and Cox were investigators on the study. Drs Rueda and Nogueira are employees of Galderma Laboratories, LP.
FUNDING/SUPPORT: Galderma Laboratories, LP, Fort Worth, Texas.

PA-03: Access of efinaconazole topical solution, 10%, to the infection site by spreading through the subungual space

Pariser DM,1 Pollak RA, 2 Pillai R,3 Olin JT4
1Virginia Clinical Research, Inc, Norfolk, Virginia, USA.
2San Antonio Podiatry Associates, San Antonio, Texas, USA
3 Dow Pharmaceutical Sciences Inc, a Division of Valeant Pharmaceuticals North America, LLC, Bridgewater, New Jersey, USA.
4 Valeant Pharmaceuticals North America, LLC, Bridgewater, New Jersey, USA.
OBJECTIVE: To evaluate the ability of efinaconazole topical solution, 10% vehicle to reach the site of toenail onychomycosis by spreading through the subungual space between the nail plate and nail bed. Lacquer-based vehicles are primarily limited to application on the nail plate and dependent on nail plate permeation.
METHODS: A total of 11 patients (mean age 48.5 years) were entered with clinically determined onychomycosis. Presence of fungal infection was confirmed by KOH testing in 8 patients. Two separate applications of vehicle (with fluorescein incorporated for better visualization) were applied at the hyponychium, avoiding application to the exterior nail plate surface. Affected nails were later clipped to allow examination of the nail bed and further examination of the underside of the nail. Spread of formulation was assessed under visible and UV light conditions by photographing target toenails after vehicle application, and after nail clipping.
RESULTS: Assessments under both visible and UV light indicated that the vehicle had spread into the subungual space, with deposition of flourescein wherever vehicle had reached, including in the nail bed. Nail clippings also indicated deposition to the underside of the nail plate.
LIMITATIONS: The relative contributions of spreading into the subungual space, or permeation through the nail plate to the efficacy of efinaconazole topical solution, 10% in treating onychomycosis were not assessed.
CONCLUSION: This study suggests that the vehicle developed for efinaconazole topical solution, 10%, when applied at the hyponychium, spreads into the subungual space between the nail plate and nail bed, reaching the site of infection.
CORRESPONDING AUTHOR: David M Pariser, Virginia Clinical Research, Inc, 601 Medical Tower, Norfolk, VA 23507. Email: [email protected].
DISCLOSURES: Drs Pariser and Pollak have served as paid consultants to Valeant Pharmaceuticals North America, LLC. Drs Pillai and Olin are employees of Valeant Pharmaceuticals North America, LLC.

PA-04: Adapalene-benzoyl peroxide gel is efficacious and safe in adult female acne

Stein-Gold L,1 Dreno B,2 Kerrouche N,3 Rueda MJ4
1 Henry Ford Medical Center, Department of Dermatology, Detroit, Michigan, USA.
2 Department of Dermatology, Nantes University Hospital, Nantes, France.
3Galderma R&D, Sophia Antipolis, France.
4Galderma Laboratories, L.P., Fort Worth, Texas, USA.
BACKGROUND: The prevalence of acne in adult (≥25 y) women has increased and although this population is often included in clinical studies, the efficacy and safety of acne treatments in adult women remains largely unknown.
OBJECTIVE: The focus of this meta-analysis was acne in adult women.
METHODS: A meta-analysis of 3 clinical studies that assessed the efficacy and safety of a fixed-dose combination gel of adapalene/ benzoyl peroxide, 0.1%/2.5% (A-BPO) was conducted with a focus on adult women. These were multicenter, randomized, double-blind, parallel group, vehicle controlled studies in which subjects were randomized to A-BPO or vehicle gel for 12 weeks.
RESULTS: A total of 254 adult women were included in the analysis. A-BPO was significantly better than vehicle gel in investigator global assessment success rate (score of clear or almost clear) at week 12 than vehicle with 39.2% of A-BPO subjects achieving success vs 18.5% of subjects on vehicle gel (P < .001). A-BPO had a quick onset of action with a significant reduction in total lesions, inflammatory lesions, and non-inflammatory lesions occurring as early as week 1 (P < .001). A-BPO was significantly better than vehicle gel at lesion reduction at every time point and by week 12 had a 71% reduction in total lesions compared to 45% for vehicle gel (P< .001). The most common related adverse events in the ABPO group were dry skin, contact dermatitis, and application site irritation.
CONCLUSION: Overall, the results of this meta-analysis support the use of A-BPO in adult female acne as A-BPO was efficacious, had a quick onset of action, and had a good safety profile. LIMITATIONS: This was a post hoc analysis of a subgroup population. A prospective study that enrolled just this population would confirm the results CORRESPONDING AUTHOR: Maria-Jose Rueda, MD, Galderma Laboratories, LP, 14501 North Freeway, Fort Worth, TX 76177. E-mail: [email protected].
DISCLOSURES: Dr Stein-Gold was an investigator and is an advisor and speaker for Galderma Laboratories, LP. Dr Dreno was an investigator for Galderma Research & Development. N Kerrouche is an employee of Galderma Reasearch & Development, France. Dr Rueda is an employee of Galderma Laboratories, LP.
FUNDING/SUPPORT: Study funded by Galderma Research & Development, SNC, poster and editorial support by Galderma Laboratories, LP.

PA-05: An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate-to-severe acne vulgaris: assessment of efficacy in 498 patients

Pariser DM,1 Rich P,2 Cook-Bolden FE,3 Korotzer A4
1Virginia Clinical Research, Inc, Norfolk, Virginia, USA. 2 Oregon Dermatology and Research Center, Portland, Oregon, USA.
3Skin Specialty Dermatology, New York, New York, USA.
4Valeant Pharmaceuticals, Bridgewater, New Jersey, USA.

BACKGROUND: Secukinumab, a fully human anti–interleukin-17A monoclonal antibody, has demonstrated rapid, robust, and sustained efficacy with an acceptable safety up to 52 weeks in moderate-to-severe plaque psoriasis. Evidence suggests that Th17/IL-17 signaling plays a role in the homeostasis of neutrophil granulopoiesis.1
OBJECTIVE: To evaluate efficacy of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (Clindamycin-BPO 3.75%) aqueous gel in moderate-to-severe acne vulgaris.
METHODS: A total of 498 patients, 12-40 years of age, were randomized to receive Clindamycin-BPO 3.75% or vehicle in a double-blind, controlled 12-week, 2-arm study evaluating efficacy (inflammatory and noninflammatory lesion counts) using Evaluator Global Severity Scores (EGSS) and subject self-assessment (SSA). In addition, patients completed a patient satisfaction survey (PSS), acne-specific QoL questionnaire, and assessed their facial skin for shininess/oiliness.
RESULTS: Clindamycin-BPO 3.75% demonstrated statistical superiority to vehicle in reducing lesions and acne severity. Median percent change from baseline to Week 12 in inflammatory and noninflammatory lesion counts was 68.4% and 57.9% versus 35.5% and 32.5% with vehicle respectively (both P <.001). Clindamycin-BPO 3.75% showed greater efficacy relative to vehicle in assessments of skin oiliness, SSA and PSS. Skin oiliness was reported to be none or mild by 84.7% of patients at week 12, and rarely bothersome.
LIMITATIONS: Data from controlled studies may differ from clinical practice. It is not possible to determine the contributions from the individual active ingredients.
CONCLUSIONS: Clindamycin-BPO 3.75% provides statistically significant greater efficacy than vehicle in moderate-tosevere acne.
CORRESPONDING AUTHOR: David M Pariser, Virginia Clinical Research, Inc, 601 Medical Tower, Norfolk, VA 23507. Email: [email protected].
DISCLOSURES: Drs Pariser, Cook-Bolden and Rich have served as paid consultants to Valeant Pharmaceuticals North America, LLC. They were investigators in the study. Dr Korotzer is an employee of Valeant Pharmaceuticals North America, LLC.

PA-06: An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate-to-severe acne vulgaris: assessment of safety in 498 patients

Pariser DM,1 Rich P,2 Cook-Bolden FE,3 Korotzer A4
1Virginia Clinical Research, Inc, Norfolk, Virginia, USA.
2 Oregon Dermatology and Research Center, Portland, Oregon, USA.
3Skin Specialty Dermatology, New York, New York, USA.
4Valeant Pharmaceuticals, Bridgewater, New Jersey, USA.

OBJECTIVE: To evaluate safety, and tolerability of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (Clindamycin-BPO 3.75%) aqueous gel in moderate-tosevere acne vulgaris.
METHODS: A total of 498 patients, 12-40 years of age, were randomized to receive Clindamycin-BPO 3.75% or vehicle in a double-blind, controlled 12-week, 2-arm study evaluating safety and tolerability.
RESULTS: No substantive differences were seen in cutaneous tolerability among treatment groups. More than 80% of patients treated with Clindamycin-BPO 3.75% had no erythema, >88% no scaling, >87% no itching, ≥95% no burning, and >95% no stinging at any post-baseline study visit. No patients discontinued treatment with Clindamycin-BPO 3.75% because of adverse events.
LIMITATIONS: Data from controlled studies may differ from clinical practice. It is not possible to determine the contributions from the individual active ingredients.
CONCLUSIONS: Clindamycin-BPO 3.75% provides a highly favorable safety and tolerability profile.
CORRESPONDING AUTHOR: David M Pariser, Virginia Clinical Research, Inc, 601 Medical Tower, Norfolk, VA 23507. Email: [email protected].
DISCLOSURES: Drs Pariser, Cook-Bolden and Rich have served as paid consultants to Valeant Pharmaceuticals North America, LLC. They were investigators in the study. Dr Korotzer is an employee of Valeant Pharmaceuticals North America, LLC.

PA-07: An in vitro study demonstrating nail penetration of tavaborole topical solution, 5% through multiple layers of nail polish

Elewski BE,1 Coronado D,2 Chanda S,2 Merchant T,2 Zane LT,2 Vlahovic T3
1 University of Alabama at Birmingham, Birmingham, Alabama, USA.
2Anacor Pharmaceuticals, Palo Alto, California, USA.
3 Temple University School of Podiatric Medicine, Philadelphia, Pennsylvania, USA
.
BACKGROUND: Topical antifungal therapies must effectively penetrate through the nail plate and into the nail bed to completely eradicate the fungal infection. Tavaborole topical solution, 5% [Anacor Pharmaceuticals] is a boron-based pharmaceutical agent approved by the US Food and Drug Administration (FDA) for the treatment of onychomycosis of the toenails. Tavaborole topical solution 5% has demonstrated a high amount of penetration through full-thickness human nail plates in vitro.
OBJECTIVE: The objective of this study was to evaluate the effect of nail polish on the nail penetration of tavaborole topical solution, 5%.
METHODS: Human cadaver fingernails from eight female donors were mounted on Vertical Diffusion Cells and were randomized to one of four treatment groups (n=7 for each). Group 1 had one coat of home brand polish; group 2 had two coats of home brand polish; group 3 had one coat of salon brand polish; and group 4 had four coats of salon brand polish (one base coat, two coats of polish, and one final clear coat). The control group included one nail from each donor that was dosed unpainted. Tavaborole topical solution, 5% was applied once daily for 14 consecutive days at a dose of 25 μL/cm2. Penetration of tavaborole topical solution, 5% was measured daily by monitoring the tavaborole concentration in the receiving medium.
RESULTS: fter 14 days, mean ± SD cumulative penetration of tavaborole was numerically higher in all groups that received nail polish (group 1: 1428 ± 841 μg/cm2; group 2: 1493 ± 1322 μg/cm2; group 3: 1227 ± 974 μg/cm2; group 4: 1179 ± 554 μg/cm2); mean penetration in the control group was 566 ± 318 μg/cm2.
LIMITATIONS: These studies were limited by their in vitro nature and use of human ex vivo fingernails.
CONCLUSION: Tavaborole topical solution, 5% effectively penetrated through four layers of nail polish.
CORRESPONDING AUTHOR: Lee Zane, MD, Anacor Pharmaceuticals, Inc, 1020 East Meadow Circle, Palo Alto, CA 94303- 4230. E-mail: [email protected].
DISCLOSURES: Ms Coronado, Dr Chanda, Dr Merchant, and Dr Zane are employees and stockholders of Anacor Pharmaceuticals, Inc. Dr Vlahovic is a remunerated speaker and advisory board participant for Anacor, Merz, and Valeant. Dr Elewski is a consultant for Anacor Pharmaceuticals, Inc.

PA-08: An innovative aerosol foam formulation of calcipotriene 0.005% plus betamethasone dipropionate 0.064% is more efficacious than Cal and BD foam alone in treating psoriasis vulgaris: a randomized, double-blind, multicenter, three-arm, Phase 2 study

Lebwohl M,1 Tyring S,2 Bukhalo M,3 Alonso-Llamazares J,4 Olesen M,5 Lowson D,5 Yamauchi P6
1 Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
2 Department of Dermatology, University of Texas, Houston, Texas, USA.
3 Altman Dermatology Associates, Arlington Heights, Illinois, USA.
4Miami VA Healthcare System, Miami, Florida, USA.
5LEO Pharma A/S, Ballerup, Denmark.
6 Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.

BACKGROUND: An investigational aerosol foam formulation of fixed combination calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) has the potential to help patients manage psoriasis.
OBJECTIVE: To investigate the comparative efficacy of Cal/ BD foam versus the active monocomponents in vehicle (vs Cal foam and vs BD foam).
METHODS: Adult patients (≥18 years) with plaque psoriasis (psoriasis vulgaris) of at least mild severity by Physician’s Global Assessment (PGA) applied Cal/BD foam, Cal foam or BD foam once daily (randomized 1:1:1) for up to 4 weeks in this double-blind, multicenter, Phase 2 study (NCT01536938). The primary endpoint was treatment success (‘clear’ or ‘almost clear’ from baseline moderate/severe disease; ‘clear’ from baseline mild disease on PGA) of the trunk and limbs at Week 4. Other evaluations included treatment success of the involved scalp, modified Psoriasis Area Severity Index (mPASI) (excluding assessment of head) and safety.
RESULTS: A total of 302 patients were randomized (100:101:101) and 93% completed the study, with similar dropout rates between arms. Most patients (76%) had moderate psoriasis (66% for the involved scalp). At Week 4, Cal/BD foam provided treatment success in 45% of patients, significantly more than Cal alone (14.9%; OR 4.34; 95% CI 2.16–8.72; P < .001) or BD alone (30.7%; OR 1.81; 95% CI 1.00–3.26; P = .047). After Week 1, the proportion of patients with treatment success was highest with Cal/BD and remained higher throughout treatment. Treatment success on scalp with Cal/BD at Week 4 (53%) was significantly greater than with Cal (35.6%; OR 1.91; 95% CI 1.09–3.35; P = .021) but not with BD (47.5%; OR 1.24; 95% CI 0.71–2.16; P = .45). Mean mPASI improved in all groups from population baseline of 7.6, with a statistically significant difference in the Week 4 Cal/BD score (2.37) vs Cal (4.39; P < .001; mean difference -2.03; 95% CI -2.63 to -1.43) and BD (3.37; P < .001; mean difference -1.19; 95% CI -1.80 to -0.59). A total of 4, 10 and 8 adverse drug reactions (ADRs) were reported with Cal/BD, Cal and BD, respectively. Within the Cal/BD foam group, all ADRs were single events. One severe and serious adverse event of hypersensitivity with Cal/BD foam led to discontinuation.
LIMITATIONS: All patients received active treatment based on the known beneficial effect of the agents studied and the fact that patients with psoriasis of any severity were eligible to enroll. Treatment efficacy of scalp psoriasis was a secondary evaluation.
CONCLUSIONS: Cal/BD aerosol foam was significantly more effective than Cal foam and BD foam in providing treatment success, with 45% achieving clear or almost clear skin at Week 4. Cal/BD foam was also effective on the involved scalp (53% clear/almost clear). The aerosol foam fixed combination shows promise as a future treatment option for psoriasis vulgaris. CORRESPONDING AUTHOR: Mark Lebwohl, Department of Dermatology, Icahn School of Medicine at Mount Sinai, 5 E 98th St, New York, NY 10029. Email: [email protected].
DISCLOSURES: Dr Lebwohl is an investigator for and/or, prior to March 2014, Dr Lebwohl was a paid consultant for AbGenomics, AbbVie, Amgen, Canfite Biopharma, Celgene, Coronado Biosciences, Dermipsor, Lilly, Forward Pharma, GSK-Stiefel, Janssen Biotech, LEO Pharmaceuticals, Maruho, Meda, Merck, Novartis, Pfizer, Taro and UCB Pharma. Dr Tyring reports grants from LEO Pharmaceuticals, outside the submitted work. Dr Bukhalo reports grants and personal fees from LEO Pharmaceuticals, outside the submitted work. Dr Alonso- Llamazares reports personal fees from Celgene, outside the submitted work. Dr Olesen reports that he was an employee of LEO Pharmaceuticals at the time of the study. Dr Olesen reports that he was an employee of LEO Pharmaceuticals at the time of the study. Mr Lowson reports that he is an employee of LEO Pharmaceuticals. Dr Yamauchi reports personal fees from AbbVie, grants and personal fees from Amgen, personal fees from Baxter, grants and personal fees from Galderma, grants and personal fees from Janssen, grants and personal fees from LEO Pharmaceuticals, grants and personal fees from Lilly ICOS LLC, personal fees from Novartis Pharmaceuticals Corp, grants and personal fees from Pfizer Inc, grants from Celgene, outside the submitted work.

PA-09: AN2728, a new boron-based topical anti-inflammatory agent, inhibits phosphodiesterase 4 (PDE4)

Freund Y, Dong C, Virtucio-Fratees C, Rock F, Mak Y, Zhou Y, Zane L, Jarnagin K
Anacor Pharmaceuticals, Inc, Palo Alto, California.
BACKGROUND: AN2728 is a boron-based topical anti-inflammatory agent currently being investigated in phase 3 clinical trials for the treatment of mild-to-moderate atopic dermatitis.
OBJECTIVE: The objectives of the studies described herein were to further characterize the mechanism of action of AN2728.
METHODS: The methodology used to characterize the mechanism of action of AN2728 included enzyme kinetic assays, 173±26 nM; thus AN2728 interacts at the enzyme active site. The X-ray structure of PDE4B-catalytic domain with AN2728, and its structural relative, AN2898, reveals that the boron atom interacts with the bimetal center and occupies a position in the catalytic site similar to that of the phosphate of cAMP. AN2728 has good affinity across the PDE4 gene products, A, B, C, and D. Its selective affinity for PDE4 is 4- to 10-fold greater than its affinity for PDE1, PDE2, PDE3A, PDE6, or PDE7B. It is inactive on PDE3B, PDE5, PDE7A1, and PDE8-11. The activity of AN2728 results in an increase in intracellular cAMP and activation of PKA, followed by phosphorylation and negative regulation of transcription factors of various cytokines. In the analysis of AN2728 binding to 50 receptors and ligand-gated ion channels, inhibition was less than 25% for all of the receptors tested; thus, AN2728 is specific for PDE4.
LIMITATIONS: This study is limited by its in vitro, exploratory nature; future studies will further define the mechanism of action of AN2728.
CONCLUSION: The novel boron-containing compound, AN2728, exerts its anti-inflammatory effect by inhibition of PDE4, one of 11 subtypes of the enzymes which catalyze the breakdown of cyclic nucleotides to their inactive monophosphates (in the case of PDE4, cAMP to AMP). Through inhibition of cAMP-dependent PDE4 activity, AN2728 inhibits the production of specific cytokines with a pattern that is notably similar to that of other established PDE4 inhibitors and distinctly different from those of a glucocorticoid and a calcineurin inhibitor.
CORRESPONDING AUTHOR: Lee Zane, MD, Anacor Pharmaceuticals, Inc, 1020 East Meadow Circle, Palo Alto, CA 94303- 4230. E-mail: [email protected].
DISCLOSURES: All authors are employees and stockholders of Anacor Pharmaceuticals, Inc.

PA-10: Antipsoriatic effect of an innovative aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate in patients with psoriasis, using a modified psoriasis plaque test

Queille-Roussel C,1 Olesen M,2 Villumsen J,2 Lacour JP1,3
1 Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Nice, France.
2LEO Pharma A/S, Ballerup, Denmark.
3Service de Dermatologie, University Hospital of Nice, France.
BACKGROUND: An innovative aerosol foam formulation of the fixed combination calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) has been developed to improve treatment for patients with psoriasis vulgaris.
OBJECTIVE: To assess the efficacy and safety of Cal/BD foam in patients with psoriasis vulgaris of the body using a modified psoriasis plaque test.
METHODS: In this Phase 2a, single-center, investigator-blinded, 4-week exploratory study with intraindividual comparison, eligible psoriatic patients aged ≥18 years, with lesions of a total size suitable for 4 different treatment applications, were each treated with the following investigational products: Cal/ BD foam, Cal/BD ointment, BD foam and foam vehicle alone (NCT01347255). Treatments were randomized to 4 test sites (5 cm2 each; on predetermined target plaques) and applied once daily (6 days/week, excluding Sundays). The primary efficacy endpoint was the absolute change in Total Clinical Score (TCS; sum of erythema, scaling and infiltration scores [TCS range 0–9]) for each test site. Secondary endpoints included changes in total skin thickness and echo–poor band thickness, expressing superficial dermis inflammation, by ultrasonography. Adverse events were monitored throughout.
RESULTS: A total of 24 patients, median age 53 years (range 21–75), completed this study. At Week 4, test sites treated with Cal/BD foam had a significantly larger decrease in the mean (±SD) TCS (–6.00 ± 1.27) compared with those treated with Cal/BD ointment (–5.25 ± 1.78; difference –0.75; 95% CI –1.46, –0.04; P = .038), BD foam (–4.96 ± 1.85; difference –1.04; 95% CI –1.75, –0.33; P = .005) or foam vehicle (–1.88 ± 1.12; difference –4.13; 95% CI –4.83, –3.42; P < .001). A continuous improvement in TCS was observed for all active treatments throughout the study. Total skin thickness of test sites treated with Cal/BD foam was reduced to a greater extent (–0.81 ± 0.41) compared with those treated with Cal/BD ointment (–0.62 ± 0.37) or BD foam (–0.66 ± 0.42), and was significantly reduced compared with foam vehicle (–0.23; difference –0.58; 95% CI –0.79, –0.36; P < .001). Echo-poor band thickness was consistently reduced to a greater extent following treatment with Cal/BD foam (–0.57 ± 0.21) compared with Cal/BD ointment (–0.46; difference –0.11; 95% CI –0.22, 0.00; P = .052) and was significantly reduced compared with BD foam (–0.45; difference –0.12; 95% CI –0.23, –0.01; P = .037) and foam vehicle (–0.12; difference –0.44; 95% CI –0.55, –0.33; P < .001). In total, 17 adverse events were reported in 11 patients, the most frequent being headache (n=5). There were no reports of lesional/perilesional adverse events or adverse drug-related events.
LIMITATIONS: The exploratory nature of this study means that findings should not be directly correlated with clinical outcomes, although the psoriasis plaque test enables intraindividual comparisons, thereby increasing the probability of detecting clinically relevant differences between treatments despite the relatively short study period and limited sample size.
CONCLUSIONS: In this exploratory study using a modified psoriasis plaque test, the innovative Cal/BD aerosol foam demonstrated a significant improvement in antipsoriatic effect compared with Cal/BD ointment, BD foam and foam vehicle alone.
CORRESPONDING AUTHOR: Catherine Queille-Roussel, Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital L’Archet 2, F-06202 Nice Cedex 3, France.Email: [email protected].
DISCLOSURES: Dr Queille-Roussel reports grants from LEO Pharmaceuticals, outside the submitted work. Dr Olesen reports that he was an employee of LEO Pharmaceuticals at the time of the study. Dr Villumsen reports that he is an employee of LEO Pharmaceuticals. Dr Lacour reports grants and personal fees from MSD, grants and personal fees from LEO Pharmaceuticals, grants and personal fees from Lilly ICOS LLC , grants and personal fees from Novartis Pharmaceuticals Corp, grants from Amgen, grants from Abbvie, grants from Pfizer, grants from Pierre Fabre Dermatologie, grants from Forward Pharma, grants from GlaxoSmithKline, grants from BMS, outside the submitted work.

PA-11: Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate-to-severe psoriasis: results of a phase 3, randomized, controlled trial (ESTEEM 2)

Paul C,1 Gooderham M,2 Cather J,3 Poulin Y,4 Girolomoni G,5 Ferrandiz C,6 Gottlieb AB,7 Mrowietz U,8 Hu C,9 Day RM,9 Crowley J10
1Toulouse University, Hôpital Larrey, Toulouse, France.
2SKiN Centre for Dermatology, Peterborough, ON, Canada.
3Modern Research Associates, Dallas, TX, USA.
4 Centre de Recherche Dermatologique du Québec métropolitain, Québec, Canada.
5University of Verona, Verona, Italy.
6Hospital Germans Trias i Pujol, Barcelona, Spain.
7Tufts Medical Center, Boston, Massachusetts, USA.
8University Hospital Schleswig-Holstein, Kiel, Germany.
9Celgene Corporation, Warren, NJ, USA.
10Bakersfield Dermatology, Bakersfield, Califorenia, USA.
BACKGROUND: Apremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. OBJECTIVE: The efficacy and safety of APR in the treatment of moderate-to-severe plaque psoriasis were evaluated in a 52- week, phase III, randomized, controlled trial.
METHODS: Patients with moderate-to-severe plaque psoriasis (PASI ≥12, BSA ≥10%, sPGA ≥3) were randomized (1:2) to placebo (PBO) or APR 30 mg BID (APR30). At Week 16, PBO patients switched to APR30 through Week 32. At Week 32, patients treated with APR30 at baseline who achieved ≥50% reduction from baseline in PASI score (PASI-50) were randomized (1:1, blinded) to continue APR30 or switch to PBO through Week 52. Upon loss of 50% of PASI improvement obtained at Week 32, patients who had been re-randomized to PBO resumed APR30.
RESULTS: The full analysis set included 411 patients (PBO: n =1 37; APR30: n = 274) (mean PASI score: 19.3; mean BSA: 26.2%; prior systemic therapy and/or phototherapy: 64.2%). At Week 16, significantly more patients receiving APR30 achieved PASI-75 (28.8%) and PASI-50 (55.5%) vs. PBO (5.8% and 19.7%; P < .0001). Mean/median percent change from baseline PASI score was –50.9/–56.0% for APR30 vs. –15.8%/–18.0% for PBO (P < .0001, mean change). PASI responses were generally maintained through Week 32. Similar PASI responses were achieved at Week 32 in PBO patients switched to APR30 at Week 16. In the randomized treatment withdrawal phase, 80.3% of the 61 patients re-randomized to APR30 at Week 32 achieved PASI-50 at Week 52, and 60.7% had ≥70% improvement in PASI from baseline; mean percent change from baseline in PASI score ranged from –73.5% to –76.7% between Weeks 32 and 52. Median time to loss of 50% of PASI improvement obtained at Week 32 in patients re-randomized to PBO was 12.4 weeks. Of patients re-randomized to PBO who lost response and restarted APR30 (n=32), 65.6% regained PASI- 50 response after re-initiation of treatment (duration of re-treatment ranged from 2.6 to 18.3 weeks). APR was generally well tolerated for up to 52 weeks, with no increase in adverse event (AE) incidence over time. During the APR-exposure period (defined as Weeks 0-52; including all patients who received APR, regardless of when initiated), AEs in ≥5% of patients were nausea (16.6%), diarrhea (14.5%), nasopharyngitis (14.5%), upper respiratory tract infection (9.2%), tension headache (7.6%), vomiting (6.3%), headache (5.8%), and back pain (5.3%). Most AEs were mild or moderate in severity and did not lead to discontinuation. No clinically meaningful changes in laboratory measurements were reported.
LIMITATIONS: Study limited to 52 weeks.
CONCLUSION: APR30 significantly reduced the severity of moderate-to-severe plaque psoriasis over 16 weeks, with response generally maintained in patients who were PASI-50 responders who continued APR30 for 52 weeks. APR30 demonstrated an acceptable safety profile and no new significant AEs emerged with continued exposure for up to 52 weeks.
DISCLOSURES: Dr Paul reports personal fees and other from Celgene Corporation, during the conduct of the study; personal fees and other from AbbVie Pharmaceuticals, personal fees and other from Amgen, personal fees and other from Janssen Pharmaceuticals Inc, personal fees and other from Lilly, personal fees and other from LEO Pharma, personal fees and other from Novartis, personal fees and other from Pfizer Inc , outside the submitted work. Dr Gooderham reports other from Celgene Corporation, during the conduct of the study; personal fees and other from AbbVie Pharmaceuticals, personal fees from Actelion Pharmaceuticals Ltd, other from Accord Healthcare, personal fees and other from Amgen, personal fees from Astellas, other from Dermira, other from Dr Reddy’s Laboratories, personal fees and other from Galderma Laboratories, personal fees from Graceway, personal fees from Janssen Pharmaceutical, other from Kythera, other from Kyowa Hakko Kirin Pharma, personal fees and other from LEO Pharma, other from Lilly, other from Novartis, other from Pfizer Inc, other from Forward- Pharma, outside the submitted work. Dr Cather reports other from Celgene Corporation, during the conduct of the study; other from Amgen, other from Galderma Laboratories, other from Merck, other from Novartis, other from Pfizer Inc, personal fees from AbbVie Pharmaceuticals, personal fees from Janssen OrthoBiotech, personal fees from Medac, outside the submitted work. Dr Poulin reports personal fees and other from Celgene Corporation, during the conduct of the study; personal fees and other from Abbvie Pharmaceuticals, personal fees and other from Amgen, other from Astellas, other from Boehringer- Ingelheim, other from Bristol Myers Squibb, personal fees and other from Centocor/Janssen, personal fees and other from Galderma Laboratories, other from Isotechnika, personal fees and other from LEO Pharma, other from Lilly, other from Merck, personal fees and other from Novartis, other from Pfizer Inc, other from Pharmascience, other from Regeneron, other from Schering, other from Stiefel/GSK , outside the submitted work. Dr Girolomoni reports personal fees and other from Celgene Corporation, during the conduct of the study; personal fees and other from AbbVie Pharmaceuticals, personal fees from Actelion, personal fees from Almirall, personal fees and other from Amgen, personal fees and other from Bioderma, personal fees from Boehringer Ingelheim, personal fees from Dompé, personal fees from Galderma Laboratories, personal fees and other from Janssen Pharmaceuticals, other from L’Oreal, personal fees from LEO Pharma, personal fees from Lilly, personal fees from Maruho, personal fees from Merck-Serono, personal fees and other from MSD, personal fees from Mundipharma, personal fees and other from Novartis, personal fees from Otsuka, personal fees and other from Pierre Fabre, personal fees and other from Pfizer Inc, other from Regeneron, other from Roche, personal fees from Rottapharm, personal fees from Shiseido, outside the submitted work. Dr Ferrandiz reports personal fees and other from Celgene Corporation, during the conduct of the study; personal fees from AbbVie Pharmaceuticals, personal fees from Janssen Pharmaceuticals Inc, personal fees from Novartis, outside the submitted work. Dr Gottlieb reports grants and personal fees from Celgene Corporation, during the conduct of the study; grants and personal fees from Amgen , personal fees from Astellas, personal fees from Akros, grants and personal fees from Centocor/Janssen, personal fees from Bristol Myers Squibb , personal fees from Beiersdorf, grants and personal fees from Abbvie Pharmaceuticals, personal fees from TEVA, personal fees from Actelion, personal fees from UCB, personal fees from Novo Nordisk, grants and personal fees from Novartis, personal fees from Dermipsor Ltd, personal fees from Incyte, grants and personal fees from Pfizer Inc, personal fees from Canfite, grants and personal fees from Lilly, grants and personal fees from Coronado, personal fees from Vertex, personal fees from Karyopharm, personal fees from CSL Behring Biotherapies for Life, personal fees from GlaxoSmithKline, grants and personal fees from Xenoport, personal fees from Catabasis, personal fees from Sanofi Aventis, personal fees from DUSA, grants from Levia, grants from Merck, outside the submitted work. Dr Mroweitz reports grants, personal fees and other from Celgene Corporation, during the conduct of the study; grants, personal fees and other from Abbott/AbbVie , grants, personal fees and other from Almirall-Hermal, grants, personal fees and other from Amgen, grants, personal fees and other from BASF, grants, personal fees and other from Biogen Idec, grants, personal fees and other from Centocor/Janssen, grants, personal fees and other from Lilly, grants, personal fees and other from Forward Pharma, grants, personal fees and other from Galderma Laboratories, grants, personal fees and other from LEO Pharma, grants, personal fees and other from Medac, grants, personal fees and other from MSD, grants, personal fees and other from Miltenyi Biotech, grants, personal fees and other from Novartis, grants, personal fees and other from Pfizer Inc, grants, personal fees and other from TEVA, grants, personal fees and other from VBL, grants, personal fees and other from Xenoport, outside the submitted work. Dr Hu re ports personal fees from Celgene Corporation, during the conduct of the study. Dr Day reports personal fees from Celgene, during the conduct of the study. Dr Crowley reports grants and personal fees from Celgene Corporation, during the conduct of the study; grants and personal fees from AbbVie Pharmaceuticals, grants and personal fees from Amgen, grants from Janssen Pharmaceuticals Inc, grants and personal fees from Lilly, personal fees from Medac, grants from Merck, grants from Pfizer Inc, grants from Regeneron, outside the submitted work.

PA-12: Apremilast in moderate-to-severe plaque psoriasis: 32-week results in patients with nail, scalp, and palmoplantar involvement (ESTEEM 2)

Crowley J,1 Cather J,2 Gooderham M,3 Sebastian M,4 Girolomoni G,5 Ferrandiz C,6 Hu C,7 Day RM,7 Beylot-Barry M8
1Bakersfield Dermatology, Bakersfield, California, USA.
2Modern Research Associates, Dallas, Texas, USA.
3 SKiN Centre for Dermatology, Peterborough, Ontario, Canada.
4Gemeinschaftspraxis Mahlow, Mahlow, Germany.
5University of Verona, Verona, Italy.
6Hospital Germans Trias i Pujol, Barcelona, Spain.
7Celgene Corporation, Warren, New Jersey, USA.
8Hôpital Haut Lévêque, CHU Bordeaux, France.

BACKGROUND: Apremilast, an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. The ESTEEM 2 trial evaluated apremilast efficacy in patients with difficult-to-treat nail, scalp, and palmoplantar psoriasis.
OBJECTIVE: The objective of this presentation is to report the results of apremilast efficacy for patients with difficult-to-treat nail, scalp, and palmoplantar psoriasis over 32 weeks of the ESTEEM 2 phase 3, randomized, placebo-controlled study.
METHODS: Patients with moderate-to-severe plaque psoriasis (Psoriasis Area and Severity Index [PASI] ≥12, body surface area [BSA] ≥10%, static Physician Global Assessment [sPGA] ≥3) were randomized 1:2 to placebo (PBO) or apremilast 30 mg BID (APR). At Week 16, PBO patients switched to APR through Week 32. At Week 32, patients treated with APR at baseline who achieved ≥50% reduction from baseline in PASI score (PASI-50) were randomized (1:1, blinded) to continue APR or receive PBO. Upon loss of 50% of PASI improvement obtained at Week 32, patients who had been re-randomized to PBO resumed APR. Nail, scalp, and palmoplantar psoriasis were assessed based on the Nail Psoriasis Severity Index (NAPSI), Scalp Physician Global Assessment (ScPGA), and Palmoplantar Psoriasis Physician Global Assessment (PPPGA).
RESULTS: The full analysis set included 411 patients (PBO: n = 137; APR: n = 274) (mean PASI score: 19.3; mean BSA: 26.2%; prior systemic therapy and/or phototherapy: 64.2%). At Week 16, significantly more patients receiving APR achieved PASI-75 (28.8%) and PASI-50 (55.5%) vs. PBO (5.8% and 19.7%, respectively; P < .0001). At Week 16, among patients with NAPSI ≥1 (n = 266), ScPGA ≥3 (n=269), or PPPGA ≥3 (n = 42) at baseline, APR demonstrated significantly greater response rates vs. PBO for psoriasis affecting nails, scalp, and palmoplantar areas. Significantly more patients receiving APR achieved NAPSI-50 (44.6%) vs PBO (18.7%; P < .0001) and the mean percent change from baseline in NAPSI score was ‑29.0% for APR vs ‑7.1% for PBO (P = .0052). Scalp and palmoplantar responses at Week 16 were 40.9% (ScPGA 0-1) vs 17.2% for PBO (P < .0001) and 65.4% (PPPGA 0-1) vs. 31.3% for PBO (P = .0315). Among patients initially randomized to APR and maintained on APR through Week 32, nail psoriasis was further improved at Week 32 (-60.0%, mean % change in NAPSI; 55.4% of patients achieved NAPSI-50). Scalp and palmoplantar responses at Week 32 were 32.4% (ScPGA 0-1) and 53.8% (PPPGA 0-1). Improvements were observed at Week 32 in PBO patients who switched to APR at Week 16. The most common adverse events (AEs) were nausea, diarrhea, nasopharyngitis, upper respiratory tract infection, tension headache, headache, and vomiting. Most AEs were mild-to-moderate in severity, and discontinuation rates due to AEs were low and similar between treatment groups (PBO: 5.1%; APR: 5.5%) during Weeks 0 to 16.
LIMITATIONS: Study limited to 52 weeks. The placebo controlled period ended at week 16, therefore the 32 week data includes an open label period and lacks a control group.
CONCLUSIONS: APR significantly reduced the severity of moderate-to-severe plaque psoriasis, including nail, scalp, and palmoplantar psoriasis, at Week 16, and improvements were observed up to Week 32. APR was generally well tolerated.
DISCLOSURES: Dr Crowley reports grants and personal fees from Celgene Corporation, during the conduct of the study; grants and personal fees from AbbVie Pharmaceuticals, grants and personal fees from Amgen, grants from Janssen Pharmaceuticals Inc, grants and personal fees from Lilly, personal fees from Medac, grants from Merck, grants from Pfizer Inc, grants from Regeneron, outside the submitted work. Dr Cather reports other from Celgene Corporation, during the conduct of the study; other from Amgen, other from Galderma Laboratories, other from Merck, other from Novartis, other from Pfizer Inc, personal fees from AbbVie Pharmaceuticals, personal fees from Janssen OrthoBiotech, personal fees from Medac, outside the submitted work. Dr Gooderham reports other from Celgene Corporation, during the conduct of the study; personal fees and other from AbbVie Pharmaceuticals, personal fees from Actelion Pharmaceuticals Ltd, other from Accord Healthcare, personal fees and other from Amgen, personal fees from Astellas, other from Dermira, other from Dr Reddy’s Laboratories, personal fees and other from Galderma Laboratories, personal fees from Graceway, personal fees from Janssen Pharmaceutical, other from Kythera, other from Kyowa Hakko Kirin Pharma, personal fees and other from LEO Pharma, other from Lilly, other from Novartis, other from Pfizer Inc, other from Forward-Pharma, outside the submitted work. Dr Sebastian has nothing to disclose. Dr Girolomoni reports personal fees and other from Celgene Corporation, during the conduct of the study; personal fees and other from AbbVie Pharmaceuticals, personal fees from Actelion, personal fees from Almirall, personal fees and other from Amgen, personal fees and other from Bioderma, personal fees from Boehringer Ingelheim, personal fees from Dompé, personal fees from Galderma Laboratories, personal fees and other from Janssen Pharmaceuticals, other from L’Oreal, personal fees from LEO Pharma, personal fees from Lilly, personal fees from Maruho, personal fees from Merck-Serono, personal fees and other from MSD, personal fees from Mundipharma, personal fees and other from Novartis, personal fees from Otsuka, personal fees and other from Pierre Fabre, personal fees and other from Pfizer Inc, other from Regeneron, other from Roche, personal fees from Rottapharm, personal fees from Shiseido, outside the submitted work. Dr Ferrandiz reports personal fees and other from Celgene Corporation, during the conduct of the study; personal fees from AbbVie Pharmaceuticals, personal fees from Janssen Pharmaceuticals Inc, personal fees from Novartis, outside the submitted work. Dr Hu reports personal fees from Celgene Corporation, during the conduct of the study. Dr Day reports personal fees from Celgene, during the conduct of the study. Dr Beylot-Barry reports other from Celgene Corporation, during the conduct of the study; other from Amgen, other from Novartis, personal fees from Pfizer Inc, personal fees and other from AbbVie Pharmaceuticals, personal fees from Janssen-Cilag, personal fees from MSD, outside the submitted work.

PA-13: Brimonidine gel 0.33% improves patient-reported outcomes in severe facial erythema of rosacea

Layton AM,1 Schaller M,2 Homey B,3 Hofmann M,4 Bewley A,5 Lehmann P,6 Nohlgård C,7 Sarwer DB,8 Kerrouche N,9 Ma YM,9 Rueda MJ,10 Winkelman W10
1 Harrogate and District NHS Foundation Trust, Harrogate, United Kingdom.
2 Department of Dermatology, Tübingen University Hospital, Germany.
3 Department of Dermatology, Medical Faculty, University of Düsseldorf, Düsseldorf, Germany.
4 Department of Dermatology and Allergy, Skin Cancer Center and Melanoma Center, Berlin, Germany.
5 Whipps Cross University Hospital and the Royal London Hospital, London, United Kingdom.
6 Center for Dermatology, Allergology, and Surgical Dermatology, Helios Clinic Wuppertal, Germany.
7Läkarhuset Odenplan, Stockholm, Sweden.
8 Departments of Psychiatry and Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
9Galderma R&D SNC, Sophia Antipolis, France.
10Galderma Laboratories, LP, Fort Worth, Texas, USA.
BACKGROUND: Brimonidine gel 0.33% (BG) is a safe and effective treatment for persistent facial erythema of rosacea. A subgroup analysis on subjects from the BG phase 2b study found that subjects with patient self-assessment scores of severe had a lower quality of life as reported by the Dermatology Life Quality Index (DLQI).
OBJECTIVE: A clinical study was conducted to assess subject- reported outcomes in subjects with a PSA score of severe who were treated with BG or vehicle gel for 8 days. Assessments included DLQI, facial redness questionnaire, subject satisfaction questionnaire, and subject diary.
RESULTS: DLQI scores were similar between the 2 treatment groups at baseline and day 8. Subjects treated with BG were more satisfied with the appearance of their skin and felt less embarrassed by their facial redness compared to subjects treated with vehicle gel (P < .05). Subjects treated with BG were also more satisfied with the time it took for the treatment to work, the improvement in facial redness, and the study treatment itself (P < .01). More subjects in the BG group reported in their diaries that they were able to control their facial redness on a daily basis. The most common adverse events occurring in at least 4% of subjects treated with BG were erythema, flushing, rosacea, skin tightness, and skin warm. One subject in the BG group discontinued due to a severe adverse event of erythema.
LIMITATIONS: This study was conducted in subjects with moderate to severe facial erythema of rosacea.
CONCLUSION: Overall, treatment with BG resulted in significantly improved subject reported outcomes and subject satisfaction compared to vehicle gel.
CORRESPONDING AUTHOR: Maria-Jose Rueda, MD, 14501 North Freeway, Fort Worth, TX 76177. E-mail: [email protected] galderma.com.
DISCLOSURES: Dr. Layton, Schaller, Homey, Hofmann, Bewley, Lehmann, Nohlgård, and Sarwer were investigators. N Kerrouche and Dr Ma are employees of Galderma Research & Development. Dr Rueda is an employee of Galderma Laboratories,LP.
FUNDING/SUPPORT: Study funded by Galderma Research & Development, SNC, poster and editorial support by Galderma Laboratories, LP.

PA-14: Coblation debridement of chronic venous ulcers: a pilot clinical case series

Sönnergren HH, Polesie S, Faergemann J
Department of Dermatology and Venereology, The Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
BACKGROUND: Coblation (Coblation® WoundWand®, Arthro- Care Corp, Austin, USA) is a recently suggested method for surgical wound debridement of acute and chronic wounds. The Coblation method is a plasma-mediated bipolar radiofrequency ablation method which in in vitro and in vivo studies has been shown to have a direct and general bactericidal effect.
OBJECTIVE: The aim of the study was to evaluate the effect of debridement using Coblation on the healing of chronic venous ulcers, the efficacy of the debridement in decreasing bacteriacolonization, and evaluation of complications to the treatment.
METHODS: The study was a prospective single centre clinical case series. Inclusion criteria were women or men 50-90 years old with a chronic, maximum 8 cm diameter venous insufficiency ulcer in need of debridement. Exclusion criteria were Ankle Brachial Index <0.8, insulin treated diabetes mellitus, immuno compromisation, current treatment with antibiotics, surgically inserted pacemaker or other electrical equipment, or BMI > 40. Wound swabs for quantitative and qualitative bacteria analysis were performed before and after debridement. Follow-up was done every second week for eight weeks.
RESULTS: Eight patients with 16 wounds were included (6 male, 2 female, mean age 62.9±10.5). Mean ulcer duration was 26.8 months. All patients were treated and followed-up according to protocol. Wound debridement was clinically efficient and easy to perform. All debridments could be perfomed in local anesthesia. 2 of 16 of the wounds healed within eight weeks. The mean quantitative bacteria count was reduced by treatment from 5.4±1.1 to 3.9±1.0 log CFU/ml. No adverse events occurred and no patient had ulcer infection in the treated wound that required systemic antibiotics.
LIMITATIONS: The study was a small clinical case series with no control group and a limited number of patients.
CONCLUSION: This study indicate that plasma-mediated bipolar radiofrequency ablation is efficient for ulcer debridement and reduce the bacterial wound load. The treatment method should be further evaluated in randomized controlled trials.
CORRESPONDING AUTHOR: Henrik H. Sönnergren, MD, Department of Dermatology and Venereology, The Sahlgrenska Academy, University of Gothenburg and Sahlgrenska University Hospital, Gröna stråket 16, Gothenburg, Sweden SE-41303. Email: [email protected].
DISCLOSURES: The authors have no disclosures.

PA-15: Comparative efficacy and safety of ivermectin cream 1% and metronidazole cream 0.75% in the treatment of papulopustular rosacea

Taieb A,1 Ruzicka T,2 Berth-Jones J,3 Peirone MH,4 Jacovella J,4 Rueda MJ,5
1 Hôpital Saint- André, Service de Dermatologie, Bordeaux Cedex, France.
2 Ludwig Maximilian University, Department of Dermatology and Allergy, Munich, Germany.
3 Dermatology Clinical Research Unit, Department of Dermatology, Nuneaton, United Kingdom.
4Galderma R&D, Sophia Antipolis, France.
5Galderma Laboratories, LP, Fort Worth, Texas, USA.

OBJECTIVE: This study was designed to demonstrate superiority of once-daily ivermectin 1% cream (IVM 1%) compared to twice-daily metronidazole 0.75% cream regarding percent reduction of inflammatory lesions in subjects with moderate to severe papulopustular rosacea, with the objectives of generating efficacy and safety data. METHODS: In this Phase 3, investigator-blinded, randomized, parallel group study, subjects applied IVM 1% cream once daily or metronidazole 0.75% cream twice daily over 16 weeks. Efficacy assessments were inflammatory lesion counts and Investigator’s Global Assessment (IGA) based on a 5-grade scale. Subject’s global improvement of rosacea was also assessed by using a 6-grade self-evaluation questionnaire at week 16. Safety assessments included incidence of adverse events (AEs) and tolerability measurements.
RESULTS: A total of 962 subjects were randomized in the study (478 in the IVM 1% cream once-daily group and 484 in the metronidazole 0.75% cream twice-daily group). At week 16, IVM 1% cream was significantly superior to metronidazole 0.75% cream in terms of percent reduction from baseline in inflammatory lesion counts (83.0% vs. 73.7%; p<.001), observed as early as week 3 (LOCF) and continuing through week 16. Success rate defined as an IGA of 0 (subjects “clear”) or IGA of 1 (subjects “almost clear”) confirmed superiority of IVM 1% cream: 84.9% vs. 75.4%, respectively (P < .001). More subjects applying IVM 1% cream rated their global improvement as “excellent” or “good,” compared to metronidazole 0.75% cream (85.5% vs. 74.8%). Incidence of AEs was comparable between groups (32.4% vs. 33.1% of subjects in the IVM 1% and metronidazole 0.75% groups, respectively), and local tolerability was better for IVM 1% cream.
CONCLUSION: Ivermectin cream 1% was significantly superior to metronidazole 0.75% cream and achieved high patient satisfaction.
CORRESPONDING AUTHOR: Maria-Jose Rueda, MD is an employee of Galderma Laboratories, LP. NEED THE PHYSICAL MAILING ADDRESS AND EMAIL FOR DR RUEDA.
DISCLOSURES: MISSING FOR ALL AUTHORS EXCEPTDr Rueda is an employee of Galderma Laboratories,LP.
FUNDING/SUPPORT: Study funded by Galderma Research & Development, SNC, poster and editorial support by Galderma Laboratories, LP.

PA-16: Correction of midface volume deficits and contour deficiencies using a large gel particle hyaluronic acid filler

David Bank D,1 Few J,2 Joseph J,3 Rueda MJ,4 Nogueira A,4 Howell S4
1 Assistant Clinical Professor of Dermatology, Columbia Presbyterian Medical Center and Director, The Center for Dermatology Cosmetic and Laser Surgery, Mount Kisco, New York, USA.
2 Clinical Professor, University of Chicago, Division of Plastic Surgery, Director, The Few Institute for Aesthetic Plastic Surgery, Health Science Clinician, Northwestern University, Chicago, Illinois, USA.
3 Director Clinical Testing of Beverly Hills, Beverly Hills, California, USA.
4Galderma Laboratories, LP, Fort Worth, Texas, USA.

BACKGROUND: Facial shape, including the shape of the cheeks, plays an important role in facial attractiveness.
OBJECTIVE: Investigate the efficacy and safety of large gel particle hyaluronic acid filler with lidocaine for midface augmentation.
METHODS: A pivotal study was conducted to investigate the efficacy and safety of large gel particle hyaluronic acid filler with lidocaine (LGP-HAL; Perlane®-L, Galderma Laboratories, LP) for midface augmentation. Subjects aged 18 years to 65 years with a Medicis Midface Volume Scale (MMVS) score of 2 (mild loss of fullness) to 4 (substantial loss of fullness) were eligible for study and randomized 3:1 to LGP-HAL or no treatment. Subjects were initially treated at baseline with an optional touch-up at 2 weeks and assessed at months 2, 3, 6, 8, 10, and 12. The primary efficacy objective was treatment success, defined as at least one grade improvement in the MMVS on both sides of the face, at 8 weeks as assessed by a blinded evaluator. Secondary endpoints included improvement in the MMVS score at all time points as assessed by a blinded evaluator or the treating investigator.
RESULTS: A significantly greater percent of subjects achieved treatment success in the LGP-HAL group vs the untreated group at 8 weeks (88.7% vs 16.0%; P < .001). LGP-HAL was significantly better than untreated at every time point through 12 months as assessed by the blinded evaluator and treating investigator (P < .001). Treatment was well tolerated with over 80% of adverse events reported after treatment being mild in severity.
LIMITATIONS: External validity may be limited due to strict eligibility criteria.
CONCLUSION: These results indicate that treatment with LGP-HAL provides significant improvement up to 12 months for the correction of midface deficiencies.
CORRESPONDING AUTHOR: Maria-Jose Rueda, MD, Galderma Laboratories, LP, 14501 North Freeway, Fort Worth, TX 76177. E-mail: [email protected].
DISCLOSURES: Drs Bank, Few and Joseph were investigators on the study. Drs Rueda and Nogueira, and Ms Howell are employees of Galderma Laboratories, LP. FUNDING/SUPPORT: Galderma Laboratories, LP, Fort Worth, Texas.

PA-17: Effect of calcipotriene plus betamethasone dipropionate topical suspension on the hypothalamic- pituitary-adrenal (HPA) axis and calcium metabolism in adolescents with extensive scalp psoriasis: an open, noncontrolled, 8-week trial

Eichenfield L,1 Ganslandt C,2, Kurvits M,2 Schlessinger J3
1 Rady Children’s Hospital and University of California, San Diego, California, USA.
2 LEO Pharma A/S, Ballerup, Denmark; 3Skin Specialists PC, Omaha, NE, USA
3Omaha Dermatology & Cosmetic Surgery, Omaha, Nebraska, USA.

BACKGROUND: Safety and efficacy of calcipotriene plus betamethasone dipropionate topical suspension (Cal/BD) has been investigated in adult patients with extensive psoriasis on body and scalp. However, no trials in adolescent patients have been conducted.
OBJECTIVE: The first of two parallel independent trials to investigate the safety and efficacy of C/BD topical suspension in adolescents with scalp psoriasis.
METHODS: This prospective, non-controlled, multi-centre trial enrolled patients in the United States aged 12–17 years with moderate-to-severe scalp psoriasis affecting at least 20% of the scalp area affected. C/BD topical suspension was applied once daily for up to 8 weeks. Primary endpoints were adverse drug reactions, subjects with serum cortisol ≤18 mcg/dL at 30 minutes, and at both 30 and 60 minutes, after injection of synthetic adrenocorticotropic hormone (ACTH) at Weeks 4 and 8, and changes from baseline in albumin-corrected serum calcium, 24-hour urinary calcium excretion and urine calcium:creatinine ratio. Other endpoints included subjects with clear or almost clear disease according to the Investigator’s Global Assessment (IGA), subjects who rated their psoriasis as clear or very mild on the Patient’s Global Assessment (PaGA) scale, and Patient’s Assessment of Itching.
RESULTS: Thirty-one subjects (19 boys and 12 girls) with a median age of 15 years were enrolled and assigned to treatment. Mean extent of scalp psoriasis was 60.4% and scalp psoriasis was graded as moderate in 67.7% of subjects at baseline. The mean weekly dose of topical suspension applied was 24.6 g/ week. One adverse drug reaction was reported and led to withdrawal from the study, ie one patient reported HPA axis suppression at Week 4 which was mild, transient and without clinical manifestations. No subjects showed signs of suppression at Week 8. There was no clinically relevant change in serum or urinary calcium. At end of treatment, 54.8% were clear or almost clear according to the IGA and 58.1% rated their scalp psoriasis as clear or very mild on the PaGA scale. At week 8, 90.3% reported no or mild itching, compared to 64.5% at baseline.
LIMITATIONS: Treatment of psoriasis of the body was not investigated in this study.
CONCLUSIONS: In this adolescent population with extensive scalp psoriasis, C/BD topical suspension was well tolerated and associated with a low incidence of HPA axis suppression that did not increase over time, and no impact on calcium metabolism. The product appeared to be efficacious with a clinically relevant improvement of itching.
CORRESPONDING AUTHOR: Lawrence F Eichenfield, Rady Children’s Hospital San Diego, 8010 Frost Street, Suite 602, San Diego, CA 92123. E-mail: [email protected].
DISCLOSURES: Dr Eichenfield reports grants and personal fees from LEO Pharmaceuticals, outside the submitted work. Dr Ganslandt reports that she was an employee of LEO Pharmaceuticals at the time of the study. Ms Kurvits reports that she is an employee of LEO Pharmaceuticals. Dr Schlessinger has nothing to disclose.

PA-18: Efficacy and safety of adapalene 0.3%/benzoyl peroxide 2.5% topical gel in moderate and severe acne vulgaris

Weiss J,1 Stein-Gold L,2 Tanghetti E,3 Bouvresse S,4 Yao M,5 Leoni M,5 Dujols C,6 Rueda MJ7
1 Gwinnett Clinical Research Center Inc, Snellville, Georgia, USA.
2 Henry Ford Medical Center, Department of Dermatology, Detroit, Michigan, USA.
3 Center for Dermatology and Laser Surgery, Sacramento, California, USA.
4Galderma International, Paris, France.
5Galderma R&D, Princeton, New Jersey, USA.
6Galderma R&D SNC, Sophia Antipolis, France.
7Galderma Laboratories, LP, Fort Worth, Texas, USA.

BACKGROUND: This multicenter, randomized, double-blind, parallel-group, vehicle- and active-controlled study compared the efficacy and safety of adapalene 0.3%/benzoyl peroxide 2.5% (0.3% A/BPO) topical gel vs vehicle in subjects with moderate to severe acne (overall population [OP]), and in a subpopulation of the OP (severe acne subjects only; severe population [SP]). The study also compared 0.3% A/BPO to adapalene 0.1%/benzoyl peroxide 2.5% (0.1% A/BPO) topical gel in the SP, but the study was not powered to compare the active groups.
OBJECTIVE: This study compared the efficacy and safety of adapalene 0.3%/benzoyl peroxide 2.5% topical gel vs vehicle in subjects with moderate-to-severe acne. METHODS: Subjects were randomized to apply 0.3% A/BPO (n=217), 0.1% A/BPO (n=217), or vehicle (n=69) once daily for 12 weeks. Co-primary efficacy endpoints included success rate (at least 2-grade improvement on IGA) and change in inflammatory (IN) and noninflammatory (NIN) lesion count from baseline to week 12. RESULTS: In the OP and SP, 0.3% A/BPO was superior to vehicle in success rate, and absolute and percent changes in IN and NIN lesion counts(P ≤ .029). 0.3% A/BPO was well tolerated, with a similar local tolerability profile to 0.1% A/BPO. Treatment-related adverse events were mild to moderate in severity. No serious AEs were reported.
LIMITATIONS: This study was not powered to drive any conclusions associated with the 0.1% A/BPO arm.
CONCLUSION: The 0.3% A/BPO topical gel showed superior efficacy to vehicle gel in both populations and was safe and well tolerated.
CORRESPONDING AUTHOR: Maria-Jose Rueda, MD, 14501 North Freeway, Fort Worth, TX 76177. E-mail: [email protected] galderma.com.
DISCLOSURES: Drs Weiss, Stein-Gold, Tanghetti, and Bouvresse were investigators. Dr Leoni, Ms Yao and Dujols are employees of Galderma Research & Development. Dr Rueda is an employee of Galderma Laboratories, LP.
FUNDING/SUPPORT: Study funded by Galderma Research & Development, SNC, poster and editorial support by Galderma Laboratories, LP.

PA-19: Efficacy of adlimumab compared with MTX or placebo by baseline BMI in a randomized controlled trial

Prussick R,1 Unnebrink K,2 Ghorayeb E3
1 Department of Dermatology, Geoge Washington University, Washington DC, USA.
2 AbbVie Deutschland GmbH & So KG, Ludwigshafen, Germany.
3 AbbVie Inc, North Chicago, Illinois, USA (affiliation at the time the work was performed).

BACKGROUND: In the CHAMPION study, a significantly greater proportion of patients achieved ≥75% improvement in the Psoriasis Area and Severity Index (PASI-75) or ≥90% improvement (PASI-90) after 16 weeks of treatment with adalimumab (ADA; 80 mg at week 0, then 40 mg every other week starting at week 1) compared with oral methotrexate (up to 25 mg/week) or placebo.
OBJECTIVE: The purpose of this analysis was to determine whether the efficacy of ADA is affected by body mass index (BMI; calculated as weight/height2).
METHODS: In the indicated psoriasis population from the CHAMPION study (ie, patients with a baseline PASI total score ≥12), an exploratory analysis examined PASI75 and PASI90 responses and Dermatology Life Quality Index (DLQI) scores through 16 weeks of treatment by baseline BMI category (<25 kg/m2 [normal weight], 25 to <30 kg/m2 [overweight], and ≥30 kg/m2 [obese]). Treatment differences between the ADA (n=99) and the methotrexate (n=95) or the placebo (n=48) groups were compared using Fisher’s exact test for PASI responses and one-way ANOVA for DLQI scores. RESULTS: In patients with baseline BMI <25 kg/m2 or 25 to <30 kg/m2, ADA treatment led to significantly greater rates of PASI- 75/90 response beginning at week 8 and continuing at weeks 12 and 16 compared with methotrexate or placebo (P < .05 for all). The PASI-75/90 response rates at week 16 with ADA, methotrexate, and placebo were 85.0%/70.0%, 43.3%/26.7%, and 28.6%/9.5%, respectively, in patients with baseline BMI <25 kg/m2 and 85.7%/53.6%, 29.3%/7.3%, and 16.7%/16.7% in patients with baseline BMI 25 to <30 kg/m2. At week 16, the PASI-75/90 response rates in patients with baseline BMI ≥30 kg/m2 were 61.3%/35.5% with ADA, 26.1%/8.7% with methotrexate, and 0%/0% with placebo. In patients with baseline BMI ≥30 kg/m2, a significant difference was observed between the ADA and the methotrexate or placebo groups in PASI75 response at weeks 8, 12, and 16 (P < .05 for all), and significantly higher PASI-90 response rates were observed with ADA compared with methotrexate at weeks 12 and 16 and compared with placebo at week 16 (P < .05 for all). Decreases from baseline in DLQI score were observed at week 16 across all baseline BMI categories, with the largest improvements observed in the ADA group.
CONCLUSIONS: In all baseline BMI categories, treatment with ADA led to significantly higher PASI75/90 response rates and more pronounced improvement to DLQI scores at week 16 compared with methotrexate or placebo.
CORRESPONDING AUTHOR: Ronald B. Prussick, Department of Dermatology, George Washington University, 6163 Executive Blvd, Rockville, MD 20852. E-mail: [email protected] aol.com.
DISCLOSURES: The authors and AbbVie scientists designed the study and analyzed and interpreted the data. All authors contributed to the development of the content; all authors and AbbVie reviewed and approved the presentation; the authors maintained control over the final content. Medical writing support was provided by Jennifer Han, MS, of Complete Publication. Solutions, LLC, Horsham, PA, USA. AbbVie funded the research and medical writing support. Dr Prussick has been a speaker for AbbVie, Celgene, Janssen, and Valeant/Medicis. Dr Unnebrink is and Dr Ghorayeb was an employee of AbbVie and may own AbbVie stock and stock options.

PA-20: Efficacy of a multimodal brightening regimen in Asian subjects with moderate-to-severe facial hyperpigmentation

Makino ET, Mehta RC
SkinMedica, an Allergan Company, Carlsbad, California
BACKGROUND: Hyperpigmentation disorders in skin of color can be especially challenging to treat due to differences in intrinsic features including melanocyte activity levels, melanosome size, density and degradation once dispersed in the stratum corneum. Due to these differences, the efficacy of hyperpigmentation treatments should be assessed in a variety of ethnicities.
OBJECTIVES: To assess the efficacy and tolerability of a multimodal skin brightening regimen in ethnic skin, specifically in subjects with skin of color and moderate-to-severe facial hyperpigmentation.
METHODS: A 12-week, single-center, open-label clinical study was conducted. Thirty-three Thai female subjects aged 19- 58 years with Fitzpatrick Skin Types IV and V were enrolled into the study. Subjects presented with moderat-to-severe facial hyperpigmentation as assessed by a score of 4-9 on an overall hyperpigmentation scale (0-9). Subjects were instructed to apply a skin brightening complex onto their facial skin, twice daily after cleansing, for twelve weeks. Subjects also applied a non-prescription retinol product (once daily in the evening), moisturizer and sunscreen. At baseline and weeks 4, 8 and 12, subjects were assessed for overall hyperpigmentation, blotch appearance (including color: light to dark, size: small to large, occurrence: slightly visible to highly visible, number: minimal to numerous, and homogeneity: very uneven to homogeneous) on a ten point scale. Standardized digital photographs and spectrocolorimeter measurements were also taken of the subjects’ facial skin at all visits. Subjects completed a self-assessment questionnaire at all follow-up visits.
RESULTS: Thirty subjects completed the study with three of the subjects lost to follow-up. Statistically significant reductions in mean scores for overall hyperpigmentation, blotch color and blotch size were observed at week 4 with continued significant reductions through week 12 (all P ≤ .04). At week 12, significant reductions in the number, homogeneity and occurrence were also observed. At weeks 4, 8 and 12, statistically significant increases in skin brightness as measured by the L* value from the spectrocolorimeter, were observed for both normal skin and a target hyperpigmented lesion (all P ≤ 0.02). The regimen was consistently highly rated by subjects at all follow-up visits with 97% and above noticing that the regimen “decreased the appearance of uneven skin tone and discolorations” and “improved the overall condition” of their skin. Standardized photography also showed the improvements observed by both the investigator and subjects.
LIMITATIONS: The small study size is a key limitation for this clinical study.
CONCLUSIONS: These study results support the efficacy and tolerability of this multimodal skin brightening regimen in skin of color subjects with moderate-to-severe facial hyperpigmentation.
CORRESPONDING AUTHOR: Elizabeth Makino, SkinMedica, Inc, an Allergan Company, 2525 DuPont Drive, MI3-450C, Irvine, CA 92623.
DISCLOSURES: The authors of this abstract are employees of SkinMedica, Inc, an Allergan Company, the sponsor for the clinical study. Ms Makino and Dr Mehta report other from Skin- Medica, Inc, an Allergan Company, during the conduct of the study; other from SkinMedica, Inc, an Allergan Company, outside the submitted work.
FUNDING/SUPPORT: All funding of the clinical study was provided by the sponsor, SkinMedica, Inc, an Allergan Company.

PA-21: Efficacy, safety, and subject satisfaction of a complete regimen to cleanse, medicate, moisturize, and photoprotect the skin of subjects with mild-to-moderate acne vulgaris

Gold M,1 Del Rosso JQ,2 Rueda MJ,3 Brandt S,3 Winkelman WJ,3
1Gold Skin Care Center, Nashville, Tennessee, USA.
2 Las Vegas Skin and Cancer; Clinics/West Dermatology and Touro University College of Osteopathic Medicine, Henderson, Nevada, USA.
3Galderma Laboratories, LP, Fort Worth, Texas, USA.

BACKGROUND: A complete treatment regimen for acne vulgaris (AV) is composed of four major components: cleansing, medicating, moisturizing, and photoprotection. Although most dermatologists are aware of the importance of proper skin care for patients with AV, many do not consistently recommend a specific skin care regimen, often allowing patients to make select products on their own. This may be problematic as some products may be detrimental to the epidermal barrier which can lead to increased skin irritation and sensitivity possibly compromising adherence, satisfaction, and the overall response to treatment. Many prescription (Rx) and over-the-counter treatments for AV can also induce increased transepidermal water loss which renders the skin more sensitive to topically applied products such as cosmetics and photoprotectants, and some therapies for AV can augment sun sensitivity.
OBJECTIVE: Despite the recognized importance of proper skin care, there is an absence in the literature of studies investigating the use of an acne specific cleanser and moisturizer with broad spectrum sunscreen, concomitantly with topical Rx therapy in patients with active AV.
METHODS: This phase 4 study evaluated a complete 3-part treatment regimen consisting of a fixed combination topical gel applied once daily used concurrently with a specified skin care program designed for use in AV, comprised of a cleanser and a moisturizer with broad spectrum SPF 30 sunscreen (Cetaphil® DermaControl™, Galderma Laboratories, LP). Efficacy, safety, and patient satisfaction were all assessed.
RESULTS: Eighty-one subjects >9 years of age, with mild-tomoderate acne used the complete 3-part regimen daily for 8 weeks. This regimen demonstrated an onset of therapeutic action as early as 2 weeks and lesion counts were significantly reduced compared to baseline after 8 weeks of treatment. Furthermore, skin shininess scores and P acnes scores assessed through photographic methods (Canfield Scientific, Inc) were also significantly reduced by week 8. Most subjects did not experience cutaneous irritation and indicated a high level of treatment satisfaction with >70% of subjects agreeing or strongly agreeing that inclusion of sunscreen formulated in a moisturizer for acne-prone skin was important to them.
LIMITATIONS: This was a small study that provided descriptive statistics.
CONCLUSION: Overall, this study supports the importance of a complete treatment regimen that is specific to the needs of patients with AV, including those undergoing topical Rx therapy, to enhance patient satisfaction and optimize therapeutic outcomes.
CORRESPONDING AUTHOR: Maria-Jose Rueda, MD, Galderma Laboratories, LP, 14501 North Freeway, Fort Worth, TX 76177. E-mail: [email protected].
DISCLOSURES: Dr Stein-Gold was an investigator on this study. Dr Del Rosso has been a consultant, speaker and has served on advisory boards for Galderma Laboratories, LP. Ms Brandt and Drs Rueda and Winkelman are employees of Galderma Laboratories, LP.
FUNDING/SUPPORT: Galderma Laboratories, Fort Worth, Texas.

PA-22: Efinaconazole topical solution, 10%: efficacy in onychomycosis patients with coexisting tinea pedis

Markinson B,1 Caldwell B2
1 Chief of Podiatric Medicine and Surgery, Leni and Peter W May Department of Orthopedic Surgery, Mount Sinai School of Medicine, New York, New York, USA.
2 Assistant Dean and Professor of Clinical Education and Clinic Operations, College of Podiatric Medicine, Kent State University, Independence, Ohio, USA.

OBJECTIVE: To evaluate efficacy of efinaconazole topical solution, 10% in onychomycosis patients with co-existing tinea pedis.
METHODS: An analysis of 1655 patients, aged 18-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from two identical multicenter, double-blind, vehiclecontrolled 48-week studies evaluating safety and efficacy. The primary endpoint was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at week 52. Three groups were compared: those patients with coexisting tinea pedis on-study (treated or left untreated), and those where no coexisting tinea pedis was reported.
RESULTS: The majorities of patients had long-standing (>5 years) onychomycosis (50.5%), more than 2 nontarget toenails additionally affected (56.7%), and were male (77.2%). On study, 352 (21.3%) patients were reported as having coexisting tinea pedis, with 215 patients (61.1%) treated in addition to receiving efinaconazole topical solution, 10% or vehicle for their onychomycosis. Efinaconazole topical solution, 10% was more effective than vehicle irrespective of the coexistence of tinea pedis, or its treatment. Complete cure rates of 29.4% were reported in those patients where coexisting tinea pedis was treated, compared to 16.1% where coexisting tinea pedis as not treated. Both cure rates were significant compared to vehicle, and in the latter group no patients treated with vehicle achieved complete cure.
CONCLUSIONS: Treatment of coexisting tinea pedis in onychomycosis patients enhances the efficacy of once daily topical efinaconazole topical solution, 10%.
CORRESPONDING AUTHOR: Bryan Markinson, DPM, FASPD, May Department of Orthopedic Surgery, Mount Sinai School of Medicine, New York, NY 10029-6574. E-mail: Bryan. [email protected].
DISCLOSURES: Drs Markinson and Caldwell have served as paid consultant to Valeant Pharmaceuticals North America LLC.

PA-23: Efinaconazole topical solution, 10%: the benefits of treating onychomycosis early

Rich P
Oregon Dermatology and Research Center, Portland, Oregon, USA.
BACKGROUND: Many onychomycosis patients suffer from long-standing disease, and/or disease that affects several toenails significantly influencing its psychological effects. We provide analysis of efficacy based on duration and spread of disease that provides important insights in the need to ideally treat the disease early.
OBJECTIVE: To evaluate efficacy of efinaconazole topical solution, 10% in onychomycosis patients with early and longstanding disease.
METHODS: An analysis of 1655 patients, aged 18-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from two identical multicenter, double-blind, vehiclecontrolled 48-week studies evaluating safety and efficacy. The primary endpoint was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at Week 52. Three groups were compared: those with early disease (<1 year), patients with a baseline disease of 1-5 years, and those with long-standing onychomycosis (>5 years).
RESULTS: The majority of patients had long-standing disease; were older, male and white. While nail involvement of the target toenail did not differ noticeably amongst the three groups, the number of nail involved did increase progressively with disease duration. Differences were seen in terms of infecting pathogens in early disease that might have important treatment implications. Efinaconazole was more effective in treating early disease, however more than 40% of patients with long-standing disease were considered treatment successes.
LIMITATIONS: A period of 52 weeks may be too brief to evaluate a clinical cure in onychomycosis. CONCLUSIONS: Treatment of onychomycosis early to avoid disease progression to other toenails is important. Once daily topical efinaconazole solution, 10% is particularly effective in these patients.
CORRESPONDING AUTHOR: Phoebe Rich, MD, Oregon Dermatology and Research Center, Portland, OR 97210. E-mail: [email protected].
DISCLOSURES: Dr Rich has served as paid consultant to Valeant Pharmaceuticals North America LLC and was a principle investigator in the efinaconazole study.

PA-24: Efinaconazole topical solution, 10% for the treatment of mild and moderate toenail onychomycosis

Rodriguez DA
Dermatology Associates/Research, Coral Gables, Florida, USA.
BACKGROUND: It is common practice to classify disease severity according to eth extent of infection involvement, describing onychomycosis as mild (25% or less nail involvement), moderate (26% - 74%) involvement and severe (>75% involvement). Numerous studies have assessed the effectiveness of onychomycosis treatment, but few provide data specifically in mild or moderate disease.
OBJECTIVE: To evaluate efficacy, safety, and tolerability efinaconazole topical solution, 10% in patients with mild (≤25% nail involvement) and moderate (>25% nail involvement).
METHODS: A subgroup analysis of patients, aged 18-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at Week 52. RESULTS: Mycologic cure rates (OC) were similar in mild and moderate onychomycosis patients treated with efinaconazole (58.2% and 55.5% respectively), but markedly different with vehicle (25.0% and 14.1% respectively). The primary endpoint, complete cure, was achieved in 25.8% of mild onychomycosis patients and 15.9% of moderate onychomycosis patients compared to 11.3% and 2.7% respectively with vehicle (both P < .001). Treatment success (percent affected target toenail ≤10%) for efinaconazole was 65.7% and 40.7% respectively depending on disease severity. Adverse events associated with efinaconazole were local site reactions and clinically similar to vehicle.
CONCLUSIONS: Once daily efinaconazole topical solution, 10% may provide a useful topical option in the treatment of mild-to-moderate onychomycosis.
CORRESPONDING AUTHOR: David A Rodriquez, MD, Dermatology Associates/Research, 1301 Ponce De Leon Blvd, Coral Gables, FL 33134. E-mail: [email protected].
DISCLOSURES: Dr Rodriguez has served as paid consultant to Valeant Pharmaceuticals North America LLC.

PA-25: Efinaconazole topical solution, 10% for the treatment of mild and moderate toenail onychomycosis: gender as a clinically relevant outcome variable

Rosen T
Department of Dermatology, Baylor College of Medicine, Houston, Texas, USA.
BACKGROUND: Men are up to three times more likely to have onychomycosis than women and yet in women it has a greater impact on quality of life. Male patients tend to be more satisfied with their treatment although little data exists on the impact of gender on outcome variables.
OBJECTIVE: To evaluate efficacy, safety, and tolerability efinaconazole topical solution, 10% in male and female onychomycosis patients.
METHODS: Patients, aged 18-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at Week 52.
RESULTS: Mycologic cure rates (OC) were greatest in female onychomycosis patients treated with efinaconazole (64.8% vs 53.7% in males), but markedly different with vehicle (22.5% and 14.8% respectively). The primary end point, complete cure, was achieved in 27.1% of female and 15.8% of moderate onychomycosis patients compared to 6.3% and 4.2% respectively with vehicle (both P < .001). Treatment success (percent affected target toenail ≤10%) for efinaconazole was 59.1% and 43.5% respectively in female and male patients. Adverse events associated with efinaconazole were local site reactions and clinically similar to vehicle.
CONCLUSIONS: Once daily efinaconazole topical solution, 10% may provide a useful topical option in the treatment of mildto- moderate onychomycosis, especially in female patients.
CORRESPONDING AUTHOR: Theodore Rosen, MD, Department of Dermatology at Baylor College of Medicine, 1977 Butler Blvd., Houston, TX 77030. E-mail: [email protected].
DISCLOSURES: Dr Rosen has served as paid consultant to Valeant Pharmaceuticals North America LLC.

PA-26: Efinaconazole topical, 10% for the treatment of toenail onychomycosis in patients with diabetes

Vlahovic TC,1 Joseph WS2
1 Temple University School of Podiatric Medicine, Philadelphia, Pennsylvania, USA.
2 Roxborough Memorial Hospital, Philadelphia, Pennsylvania, USA.

BACKGROUND: Approximately one in three people with diabetes are afflicted with onychomycosis, and diabetic individuals suffer from a much higher incidence; especially males, older patients and those with severe nail changes. Although numerous studies have assessed the effectiveness of antifungal drugs in treating onychomycosis, most exclude patients with diabetes and examine otherwise healthy individuals.
OBJECTIVE: To evaluate efficacy, safety, and tolerability efinaconazole topical solution, 10% in diabetic patients with onychomycosis
METHODS: A post hoc analysis of 112 patients, aged 29-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary endpoint was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at Week 52.
RESULTS: Mycologic cure rates (OC) were significantly greater with efinaconazole (56.5% and 56.3% in diabetic and nondiabetic patients respectively) compared to vehicle (P = .016 and P < .001 respectively). The primary end point, complete cure, was also greater for efinaconazole (13.0% and 18.8% respectively vs 3.7% and 4.7%). Treatment success (percent affected target toenail ≤10%) for efinaconazole was 40.8% and 47.7% respectively vs 18.5% and 18.2% with vehicle. There was no statistically significant difference between the diabetic and non-diabetic populations for any efficacy endpoint. Adverse events associated with efinaconazole were local site reactions and clinically similar to vehicle.
CONCLUSIONS: Once daily efinaconazole topical solution, 10% may provide a useful topical option in the treatment of diabetic patients with onychomycosis. CORRESPONDING AUTHOR: Tracey C Vlahovic, Temple University School of Podiatric Medicine, Philadelphia, PA 19107. E-mail: [email protected].
DISCLOSURES: Dr Joseph and Vlahovic have served as paid consultants to Valeant Pharmaceuticals North America LLC. Dr Vlahovic was a principle investigator in the pivotal trials with efinaconazole topical solution, 10%.

PA-27: Enhancing the transungual delivery of efinaconazole through a unique formulation approach

Kircik LH1-3
1 Department of Dermatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
2Physicians Skin Care, PLLC, Louisville, Kentucky, USA.
3Department of Dermatology, Mount Sinai School of Medicine, New York, New York, USA.

BACKGROUND: Transungual delivery of an effective antifungal would seem ideal for the successful treatment of onychomycosis. However, the applied active drug must permeate through the dense keratinized nail plate and reach the deeper layers, the nail bed and the nail matrix in sufficient concentration to eradicate the infection. So far, formulating antifungals to achieve optimal transungual delivery of active drug has been a challenge.
METHODS: A unique formulation approach was employed in the development of a new topical antifungal, efinaconazole. The final alcohol-based formulation was developed from an extensive range of prototypes, and the unique combination of ingredients provides low surface tension and good wetting properties. Key properties; including keratin affinity, nail permeation and fungicidal activity were tested in a series of in vitro and in vivo experiments.
RESULTS: Efinaconazole was shown to have considerably lower binding to keratin, and keratin-bound drug released at a faster rate when compared to lacquer formulations like amorolfine and ciclopirox. Efinaconazole free drug and keratin release levels were at least 6-fold higher. In toenails of patients with onychomycosis, the mean concentration of efinaconazole was more than 50,000 times the MIC values (≤0.0020−0.06 μg/ml) for dermatophytes recovered in Phase 3 clinical studies with efinaconazole topical solution, 10%. Efinaconazole showed comparable fungicidal activity in keratin media (mimicking the keratin-rich environment of the nail plate and nail bed) to amorolfine, and was superior to ciclopirox. In addition, efinaconazole produced a region of growth inhibition under the nail (2.52 ± 0.42 cm, mean ± SD), whereas ciclopirox 8% and amorolfine 5% nail lacquers did not.
CONCLUSIONS: The unique formulation approach to the development of efinaconazole topical solution, 10% resulted in high concentrations of an effective, broad-spectrum antifungal in the nail bed and matrix.
CORRESPONDING AUTHOR: Leon H Kircik, MD, Physicians Skin Care, PLLC, Louisville, KY 40217. E-mail: wedoderm @yahoo.com.
DISCLOSURES: Dr Kircik has served as paid consultant to Valeant Pharmaceuticals North America LLC.

PA-28: Evaluation of the appearance of nail polish following daily treatment of ex vivo human fingernails with topical solutions of tavaborole or efinaconazole

Coronado D, Chanda S, Merchant T, Zane L
Anacor Pharmaceuticals, Inc, Palo Alto, California, USA.
BACKGROUND: Onychomycosis, a fungal infection of the nail causing thickening and discoloration, can negatively impact patient self-image. Patients may choose to mask infected nails with polish. Tavaborole topical solution, 5% is a novel, boronbased, small-molecule pharmaceutical approved by the FDA for the treatment of toenail onychomycosis caused by Trichophyton rubrum and T. mentagrophytes; efinaconazole topical solution, 10% is also approved for the same indication. The package insert for efinaconazole instructs against use of nail polish during treatment.
OBJECTIVE: The objectives of this study were to evaluate: 1) the appearance of nail polish after daily dosing with the specific applicators used for tavaborole (dropper) and efinaconazole (brush); 2) the appearance of applicators after daily dosing of tavaborole or efinaconazole on polished nails; and 3) any color transfer from the respective applicators after dosing polished nails.
METHODS: A sample of 12 ex vivo human nails were cleaned and polished with two coats of L’Oreal Nail Color, Devil Wears Red #420 nail polish. Nails were treated with tavaborole or efinaconazole solutions once daily for 7 days. Dropper and brush applicators were used to apply the solutions to while watercolour paper immediately after dosing nails to assess color transfer from the polish. Nails, applicators, and watercolour papers were photographed daily following application.
RESULTS: Tavaborole-treated polished nails showed no signs of polish discoloration and the tavaborole dropper applicators did not change in appearance during the 7-day treatment period. No color transfer from polished nails was evident on the dropper applicator or watercolour paper. Efinaconazole-treated polished nails showed polish irregularities after the first day of treatment, with polish appearance becoming progressively worse over 7 days of treatment. Polish color transfer from nails to the brush applicator, the watercolour paper, and the solution remaining in the bottle was evident.
LIMITATIONS: Limitations of this study include the small sample size, the in vitro study design, and use of nondiseased, ex vivo human nails.
CONCLUSION: Daily dropper application of tavaborole to ex vivo polished nails did not alter nail polish appearance, while brush application of efinaconazole resulted in substantial alterations to polish and polish transfer from nails to brush applicators. Previous studies have shown effective penetration of tavaborole through the nail plate in the presence of up to 4 layers of home or salon brand nail polish. Taken together, these results suggest topical treatment with tavaborole may be compatible with concomitant use of nail polish.
CORRESPONDING AUTHOR: Lee Zane, MD, Anacor Pharmaceuticals, Inc, 1020 East Meadow Circle, Palo Alto, CA 94303- 4230. E-mail: [email protected].
DISCLOSURES: Ms Coronado, Dr Chanda, Dr Merchant, and Dr Zane are employees and stockholders of Anacor Pharmaceuticals, Inc.

PA-29: Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) exhibits no clinically relevant impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, open label, 4-week MUSE study

Taraska V,1 Tuppal R,2 Olesen M,3 Pedersen CB,3 Papp K4
1The Derm Centre, Winnipeg, Canada.
2Oshawa Clinic, Oshawa, Canada.
3LEO Pharma A/S, Ballerup, Denmark.
4 K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.

BACKGROUND: Ointment and gel formulations of fixed combination Cal plus BD have demonstrated favorable efficacy and safety profiles as first-line treatments. A new aerosol foam formulation has been developed.
OBJECTIVE: This study evaluated the potential systemic effects of Cal/BD foam on the hypothalamic–pituitary–adrenal (HPA) axis and calcium homeostasis in patients with extensive psoriasis vulgaris.
METHODS: In this multicenter, single-arm, open-label, 4-week maximal-use systemic exposure (MUSE) trial, adult patients (≥18 years) with extensive psoriasis on the body and the scalp (15%-30% body surface area [BSA] including ≥30% scalp involvement) of moderate/severe disease severity according to the Physician’s Global Assessment (PGA) applied Cal/BD foam once daily for 4 weeks (NCT01600222). The primary endpoints were the number of patients with an abnormal adrenocorticotropic hormone (ACTH) challenge test (serum cortisol ≤18 mcg/dL after 30 minutes) at Week 4, and change in albumin-corrected serum calcium (sCa), 24-hour urinary calcium excretion (24hCa) and urinary calcium:creatinine ratio (Ca:Crea) from baseline to Week 4. Adverse events (AEs) were reported throughout. Efficacy by PGA on body psoriasis was a secondary endpoint.
RESULTS: Thirty-seven patients received treatment and 35 completed the study. At baseline, 24% had severe disease on PGA; mean BSA involvement was 21%. Mean 62 g/week Cal/BD foam was used. All patients reaching Week 4 exhibited normal responses to ACTH stimulation (100% [35/35] achieved serum cortisol >18 mcg/dL). Changes in all median and individual calcium homeostasis values from baseline to Week 4 were minor and not clinically relevant; no patients had calcium homeostasis elevations at Week 4. Median change from baseline to Week 4 in sCa was –0.020 mmol/L, in 24hCa was –0.30 mmol/24h and in Ca:Crea was 0.05 mmol/g. Four of six patients with low sCa values at baseline shifted into the normal range (2.15–2.55 mmol/L) by Week 4; one patient shifted from normal baseline to low levels. Seven patients shifted 24hCa values (three from low to normal, three from normal to low, one from high to normal; normal range 2.5–7.5 mmol/24 h). Elevated Ca:Crea values (0.225–8.2 mmol/g for women and 0.3–6.1 mmol/g for men) were not seen; the only shift was a patient with normal baseline values shifting to low Week 4 values. Four patients (11%) reported six AEs of mostly mild or moderate intensity. Of these, one event was considered probably related to treatment (severe erythema). No serious AEs were reported. Cal/BD foam provided clear or almost clear disease status (treatment success) in 49% of patients according to PGA at Week 4. Mild disease was achieved by 37%, and the remainder had moderate disease.
LIMITATIONS: This trial enrolled patients with extensive disease, so all patients received active treatment (placebo was unethical). Assessment bias is considered limited since most of the endpoints were laboratory data.
CONCLUSON: In patients with extensive psoriasis vulgaris treated once daily with Cal/BD foam for 4 weeks, no clinically relevant impact on the HPA axis and calcium homeostasis was observed. Cal/BD foam also demonstrated a favorable safety profile.
CORRESPONDING AUTHOR: Victoria Taraska, The Derm Centre, 1385 Grant Avenue, Winnipeg, MB, R3M 1Z9, Canada. Email: [email protected].
DISCLOSURES: Dr Taraska reports personal fees from LEO Pharmaceuticals, personal fees from Basilea, personal fees from Amgen, personal fees from Galderma, personal fees from AbbVie, personal fees from Allergan, personal fees from Cipher, personal fees from Valeant, outside the submitted work. Dr Tuppal reports personal fees from LEO Pharmaceuticals, personal fees from Amgen, personal fees from Galderma, personal fees from Novartis Pharmaceuticals Corp, personal fees from Schering (MSD), personal fees from Valeant, personal fees from Pfizer, outside the submitted work. Dr Olesen reports that he was an employee of LEO Pharmaceuticals at the time of the study. Mr Pedersen reports that he is an employee of LEO Pharmaceuticals. Dr Papp reports grants and personal fees from Janssen, personal fees from Johnson & Johnson, personal fees from Kirin, grants and personal fees from Kyowa, grants and personal fees from LEO Pharmaceuticals, personal fees from Lypanosys, grants and personal fees from Merck, personal fees from Mitsubishi Pharma, grants and personal fees from Novartis Pharmaceuticals Corp, personal fees from Pan Genetics, grants and personal fees from Pfizer , personal fees from Roche, grants and personal fees from Merck-Serono, grants and personal fees from Takeda, grants and personal fees from UCB, grants and personal fees from Vertex, grants from Stiefel, grants from Wyeth, grants from Kirin, during the conduct of the study.

PA-30: Improvement of signs of xerosis and pruritus in elderly subjects using a skincare regimen formulated with filaggrin and ceramide technology

Chang ALS,1; Chen S,2 Brandt S,3 Rueda MJ3
1 Assistant Professor of Dermatology, Stanford University School of Medicine, Stanford, California, USA.
2 Associate Professor of Dermatology, Emory Healthcare, Stanford, California, USA.
3Galderma Laboratories, LP, Atlanta, Georgia, USA.

BACKGROUND: Aging skin progressively degenerates, which results in reduced hydration, reduced lipid content, and reduced skin thickness among other changes; xerosis and pruritus are common manifestations of these changes.
OBJECTIVE: Assess the performance and tolerability of a body wash and moisturizer regimen formulated with filaggrin ceramide technology on subjects with xerosis and pruritus.
METHODS: A clinical study was conducted in subjects aged 60 y and older to assess the performance and tolerability of a body wash and moisturizer formulated with filaggrin ceramide technology (Cetaphil RestoraDerm Body Wash [CRW] and Cetaphil RestoraDerm Moisturizer [CRM]). Subjects with xerosis and pruritus were eligible for enrollment and used CRW once daily and CRM at least once daily after bathing and as needed for 15 days. Assessments included evaluator assessed dryness (primary), ItchyQuant™, ItchyQoL™, subject satisfaction, corneometry, transepidermal water loss (TEWL), and desquamation index (DI).
RESULTS: Twenty-five subjects enrolled with a mean age of 64.6 years. Investigator assessed dryness, skin hydration, DI scores, ItchyQuant™, and ItchyQoL™ scores significantly improved from baseline to day 15. TEWL scores also improved, but were not significant. A majority of subjects reported that the regimen soothed irritated skin, relieved itchy skin, improved skin texture, and made skin feel softer. No adverse events were reported.
LIMITATIONS: This was a small study that provided descriptive statistics.
CONCLUSION: Overall, a regimen of CDW and CDM improved skin dryness and pruritus as well as skin barrier function, and was well liked by subjects over the age of 60 y.
CORRESPONDING AUTHOR: Maria-Jose Rueda, MD, Gladerma Laboratories, LP, 14501 North Freeway, Fort Worth, TX 76177. E-mail: [email protected].
DISCLOSURES: Dr Chen’s research laboratory at Emory University receives royalties for usage of the ItchyQoL and Itchy- Quant. Ms Brandt and Dr Rueda are employees of Galderma Laboratories, LP.
FUNDING/SUPPORT: Galderma Laboratories, LP, Fort Worth, TX.

PA-31: Ingenol mebutate gel, 0.05%, for patients with actinic keratosis of the scalp

Bettencourt MS
Medical Director, Bettencourt Skin Center and Assistant Clinical Professor of Dermatology, University of Nevada, Las Vegas, Nevada, USA.
BACKGROUND: Ingenol mebutate gel, 0.015%, applied daily for 3 consecutive days, is indicated for the treatment of actinic keratosis (AK) of the face and scalp. Clearance rates on the scalp have been lower than those on the face, suggesting that AKs on the scalp may be more difficult to treat. This observation has prompted clinical use of the 0.05% formulation for patients with scalp AK.
OBJECTIVE: To retrospectively analyze the charts of patients from a community dermatology practice who used ingenol mebutate gel, 0.05%, to treat AK of the scalp.
METHODS: This chart review extracted non-identifying information from patients’ medical history, pertinent history of AK and skin cancer, and prior AK treatments. Information was also collected on patients’ treatment of scalp AK with ingenol mebutate gel, 0.05%, including occurrence of local skin reactions (LSRs) and their treatment, adverse events (AEs), short-term efficacy, and long-term follow-up.
RESULTS: Seventy-eight male patients with scalp AKs were treated with ingenol mebutate 0.05% gel from January 2013 to August 2014. Over their prolonged history of new and recurrent scalp AKs, these patients had undergone prior treatment with cryosurgery and topical agents, including ingenol mebutate gel, 0.015%. At the time of initiating treatment, with ingenol mebutate gel, 0.05%, the patients in this chart review had a significant proportion of their scalp affected with numerous AKs (69% of patients had ≥15 AKs) that were often recurrent and/ or hyperkeratotic. The majority of patients, 83%, received cryosurgery to all visible AKs 2 weeks before topical treatment. All patients experienced LSRs that began on the first day of treatment. Nearly all patients experienced erythema, flaking/scaling, and crusting, which was generally assessed as mild or moderate in intensity. While approximately 32% of patients experienced vesiculation/pustulation, fewer had erosion/ulceration or swelling. For 44% of the patients, the LSRs were treated with a topical moisturizing product. LSRs resolved by 10 to 14 days in almost all patients. Less than half (45%) of the patients reported application-site reactions described as a combination of burning, itching, pain, and/or tenderness that was mild or moderate in intensity and lasted only a few days. Most patients (92%) had ≥75% to 100% short-term clearance of scalp AKs. The number of remaining AKs was low, a median of 3 (range, 1 to 13); most were treated with cryosurgery. Eleven patients (14%) underwent a second treatment course with the 0.05% formulation.
LIMITATIONS: This study was limited to a retrospective chart review of patients from a single practice. Evaluations were based on clinical assessments alone, as no histopathologic analysis of biopsy samples was performed.
CONCLUSIONS: Ingenol mebutate gel, 0.05%, was used to safely and effectively treat AKs on the scalp of 78 male patients who had a prolonged history of AK that included prior treatments with cryosurgery and topical agents. LSRs developed on the first day of treatment, were predominantly mild or moderate in intensity, and generally were resolved at 10 to 14 days. More than 90% of patients achieved ≥75% to 100% short-term clearance of scalp AK. The small number of AKs present at follow-up was managed with cryosurgery.
CORRESPONDING AUTHOR: Miriam Bettencourt, MD, Bettencourt Skin Center, 1701 N Green Valley Parkway, #7B, Henderson, NV 89074. E-mail: [email protected].
DISCLOSURES: The author has nothing to disclose.

PA-32: Ingenol mebutate 0.015% gel follow-up use for multiple actinic keratoses on face and scalp: a randomized 12-month phase 3 study

Garbe C,1 Thomas Larsson T,2Venkata R,2 Knudsen KM,2 Lear J,3 Basset Seguin N,4 Poulin Y5
1 Department of Dermatology, Division of Dermatooncology, University Hospital Tübingen, Tübingen, Germany.
2 LEO Pharma A/S, Ballerup, Denmark.
3 Department of Dermatology, Manchester Royal Infirmary and Manchester Academics Health Science Centre, Manchester University, Manchester, United Kingdom.
4Hopital Saint-Louis, Paris, France.
5 Laval University, Quebec City and Center for Research in Dermatology, Quebec, Canada.

BACKGROUND: Actinic keratoses (AKs) develop in a cancerized field where epithelial cells in a photodamaged area are susceptible to the development of multiple clinically apparent and subclinical AKs, which may progress to malignancy. The chronic nature of AK necessitates repeated field treatments. Ingenol mebutate (IngMeb) gel is a novel topical field therapy for AK.
OBJECTIVE: To evaluate the efficacy of IngMeb in treating AKs present after initial field treatment or those emerging in a previously cleared field.
METHODS: In this phase 3, multicenter, randomized, doubleblind, vehicle-controlled study (NCT01600014), patients ≥18 years with 4–8 discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp were treated with open-label IngMeb once daily for 3 consecutive days. Patients were then randomized 2:1 to IngMeb or vehicle gel if AKs were still present in the field at 8 weeks after initial treatment, or if AKs emerged in the previously cleared treatment field at week 26 or 44 (emergent AKs). Patients were followed for 12 months. The primary endpoint was complete clearance of AKs in the treatment area or of those emerging in a previously cleared field 8 weeks after randomization. Secondary endpoints included complete clearance in the treatment area through 12 months and change in AK lesion counts in the selected treatment area from baseline to 8 weeks after randomization.
RESULTS: The majority (87%) of patients had been previously treated for AK; median duration of AK was 6 years. Of 450 patients enrolled, 141 patients were randomized at 8 weeks, 40 at 26 weeks, and 22 at 44 weeks after initial treatment. Overall clearance 8 weeks after initial treatment was 61.6%; following a second treatment cycle, IngMeb achieved a significantly greater level of clearance vs vehicle 8 weeks after randomization in patients with both AKs present in the field at the initial 8-week efficacy evaluation (46.7% vs 18.4%, respectively; P = .001) and emergent AKs (59.5% vs 25.0%, respectively; P = .013). In addition, significant reductions in AK lesion counts were observed at 8 weeks after randomization in patients treated with IngMeb vs vehicle, both in patients with AKs present at the initial 8-week efficacy evaluation (mean change -1.41 vs -0.51, respectively; P < .001) and in those with emergent AKs (-1.52 vs -0.85, respectively; P = .008). Of the 340 completers who were treated twice with IngMeb, or once and remained clear at 8, 26, and 44 weeks, 50.0% were still clear of AKs at 12 months (95% confidence interval 44.0%, 56.1%).
LIMITATIONS: Tracking of individual AK lesions was not employed in this study; therefore, it was not possible to determine whether the presence of AKs at the initial 8-week efficacy evaluation was due to persistent or emergent AKs (or both), or if emergent lesions over the duration of the study were derived from recurrent baseline lesions or subclinical lesions.
CONCLUSION: This is the first study to investigate the efficacy of follow-up IngMeb treatment of AKs still present in the field at 8 weeks after initial field treatment or of AKs emerging in a previously cleared field. At 12 months, 50.0% of patients receiving either one or two cycles of IngMeb treatment were clear of AKs. Both initial treatment with IngMeb, and follow-up treatment for AKs present in the field at 8 weeks and emergent AKs at 26 and 44 weeks, are highly efficacious, with no decrease in efficacy after follow-up use.
CORRESPONDING AUTHOR: Claus Garbe, MD, The university Hospital of Tübingen, Geschwister-Scholl-Platz, Tübingen, 72704 Germany. E-mail: [email protected]
DISCLOSURES: Prof Garbe reports personal fees from LEO, during the conduct of the study; personal fees from Amgen, grants and personal fees from BMS, grants and personal fees from GSK, personal fees from MSD, personal fees from Novartis, and grants and personal fees from Roche, outside the submitted work. Dr Larsson is a salaried employee of LEO Pharma. Dr Venkata is a salaried employee of LEO. Dr Knudsen is a salaried employee of LEO. Dr Lear reports advisory board and speaker fees from LEO, during the conduct of the study; and advisory board fees from Galderma and Meda outside the submitted work. Dr Basset Seguin reports consultancy fees and honoraria from LEO, during the conduct of the study. Dr Poulin reports grans and speakers’ bureau fees from LEO, during the conduct of the study; grants and speakers bureaus fees from AbbVie, grants and speakers bureau fees from Amgen, grants and speakers bureau fees from Celgene, grants and speakers bureau fees from Janssen/Centocor, grants from Boehringer Ingelheim, grants from Eli Lilly, grants from Merck, grants from Novartis, grants from Pfizer, grants from Regeneron, grants from Takeda, grants and speakers bureau fees from Hoffmann La Roche, and grants and speakers bureau fees from Dermira, outside the submitted work.

PA-33: Innovation in papulopustular rosacea treatment: efficacy and safety of ivermectin 1% cream

Stein-Gold L,1 Kircik L,2 Fowler J,3 Tan J,4 Draelos Z,5 Fleischer A,6 Appell M,7 Steinhoff M,8 Lynde C,9 Liu H,10 Jacovella J,11 on behalf of the Ivermectin Phase 3 study group, Rueda MJ12
1 Henry Ford Medical Center, Department of Dermatology, Detroit, Michigan, USA.
2Derm Research, PLLC, Louisville, Kentucky, USA.
3Dermatology Specialists Research, Louisville, Kentucky, USA.
4 Western University and Windsor Clinical Research, Inc, Windsor, Ontario, Canada.
5 Department of Dermatology, Duke University School of Medicine, Durham, North Carolina, USA.
6 Department of Dermatology, Wake Forest University Health Sciences, Winston, Salem, North Carolina, USA.
7 Total Skin and Beauty Dermatology Center, PC, Birmingham, Alabama, USA.
8 University of California-San Francisco, San Francisco, California, USA.
9 Lynderm Research, Inc, Markham, Ontario, Canada.
10Galderma R&D, Cranbury, New Jersey.
11Galderma R&D, SNC, Sophia Antipolis, France.
12Galderma Laboratories, LP, Fort Worth,Texas, USA.
BACKGROUND: Papulopustular rosacea (PPR) is an inflammatory, chronic facial skin disease characterized by persistent erythema and papules and pustules. Its exact cause remains unknown, but dysregulation of the innate immune system is believed to play a role. An increased density of Demodex folliculorum in patients with PPR may also be a contributing factor. Ivermectin is an avermectin-class drug used to treat parasites. Immunopharmacological studies have shown this class of drugs to have anti-inflammatory properties through inhibition of inflammatory cytokines and induction of anti-inflammatory cytokines.
OBJECTIVE: The objective of this study was to determine the efficacy and safety of ivermectin 1% cream in the treatment of papulopustular rosacea.
METHODS: Two phase 3 clinical studies investigated the efficacy and safety of once-daily ivermectin 1% cream (IVM) in subjects with moderate to severe PPR. These were multicenter, randomized, double-blind, parallel-group, vehicle-controlled studies of identical design lasting 12 weeks for the first part of a 3 part study. Men and women at least 18 years old with an investigator global assessment (IGA) score of moderate or severe and 15 to 70 inflammatory lesions were enrolled and randomized 2:1 to IVM or vehicle cream.
RESULTS: A significantly higher percent of subjects in each study achieved treatment success at week 12 (IGA of clear or almost clear) with IVM than vehicle cream (both P < .001). Week 12 reductions in inflammatory lesions were also significantly better with IVM over vehicle cream (both P < .001). IVM was well tolerated; 3.4% of subjects reported a related adverse event compared to 7.2% for vehicle cream.
CONCLUSIONS: The results of these studies indicate that IVM is an effective and safe treatment for inflammatory lesions of PPR.
CORRESPONDING AUTHOR: Maria-Jose Rueda, MD, 14501 North Freeway, Fort Worth, TX 76177. E-mail: Marie-Jose. [email protected].
DISCLOSURES: Drs Stein-Gold, Kircik, Fowler, Tan, Draelos, Fleischer, Appell, Steinhoff, and Lynde were investigators. Dr Jacovella and Ms Liu are employees of Galderma Research & Development. Dr Rueda is an employee of Galderma Laboratories, LP.
FUNDING/SUPPORT: Study funded by Galderma Research & Development, SNC, poster and editorial support by Galderma Laboratories, LP.

PA-34: Malignancies in the psoriasis longitudinal assessment and registry (PSOLAR) study: current status observations

Stein-Gold L,1 Kircik L,2 Fowler J,3 Jackson JM,4 Tan J,5 Draelos Z,6 Fleischer A,7 Appell M,8 Steinhoff M,9 Lynde C,10 Sugarman J,11 Liu H,12 Jacovella J,13 on behalf of the Ivermectin Phase 3 study group
1 Galderma Clinical Investigator for Phase 3 Studies of Soolantra® (ivermectin) Cream, 1%, Detroit, Michigan, USA.
2 Icahn School of Medicine at Mount Sinai and DermResearch, PLLC, Louisville, Kentucky, USA.
3Dermatology Specialists Research, Louisville, Kentucky, USA.
4 University of Louisville, Div of Dermatology, Louisville, Kentucky, USA.
5 Western University and Windsor Clinical Research, Inc, Windsor, Ontario, Canada.
6 Department of Dermatology, Duke University School of Medicine, Durham, North Carolina, USA.
7 Department of Dermatology, Wake Forest University Health Sciences, Winston, Salem, North Carolina, USA.
8 Total Skin and Beauty Dermatology Center, PC, Birmingham, Alabama, USA.
9 Department of Dermatology and UCD Charles Institute for Translational Dermatology, University College Dublin, Dublin, Ireland.
10Lynderm Research, Inc, Markham, Ontario, Canada.
11Redwood Family Dermatology, Santa Rosa, California, USA.
12 Galderma R&D, Cranbury, NJ; 13Galderma R&D, Sophia Antipolis, France.

BACKGROUND: Papulopustular rosacea (PPR) is a chronic, inflammatory facial skin disease characterized by inflammatory lesions. There is no cure for rosacea and managing the disease frequently requires long-term treatment. Ivermectin (IVM) 1% cream contains ivermectin, a semi-synthetic derivative that belongs to the avermectin family of macrocyclic lactones and has demonstrated anti-inflammatory and anti-parasitic activity in vitro and in vivo.
OBJECTIVE: To show the long-term safety of IVM 1% cream vs azelaic acid (AzA) 15% gel.
METHODS: IVM 1% cream has been shown to be safe and efficacious in two 12-week phase 3 trials. Two 40-week extension studies of those phase 3 trials assessed the long-term safety of IVM 1% cream vs azelaic acid (AzA) 15% gel. Subjects initially treated with IVM 1% cream QD continued and those initially treated with vehicle gel QD were switched to AzA 15% gel BID.
RESULTS: The incidence of adverse events (AEs) was similar between the 2 treatment groups in both studies. However, there was a lower incidence of related AEs with IVM 1% cream vs AzA 15% gel and no subjects in the IVM 1% cream group discontinued due to a related AE. The observed efficacy with IVM 1% cream continued to increase throughout the trial as the percentage of subjects with an investigator global assessment (IGA) score of clear or almost clear was higher at the end of the study than baseline.
CONCLUSION: The results of these 2 studies, in conjunction with the phase 3 studies, support the use of IVM 1% cream for the long-term management of PPR as a safe and efficacious treatment.
CORRESPONDING AUTHOR: Maria-Jose Rueda, MD, 14501 North Freeway, Fort Worth, TX 76177. E-mail: Marie-Jose. [email protected].
DISCLOSURES: Drs Stein-Gold, Kircik, Fowler, Jackson, Tan, Draelos, Fleischer, Appell, Steinhoff, and Lynde were investigators. Dr Sugarman has no conflicts. Dr Rueda is an employee of Galderma Laboratories, LP.
FUNDING/SUPPORT: Study funded by Galderma Research & Development, SNC, poster and editorial support by Galderma Laboratories, LP.

PA-35: Long-term safety of ivermectin 1% cream vs azelaic acid 15% gel in treating inflammatory lesions of rosacea

Fiorentino D,1 Lebwohl M,2 Ho V,3 Langley R,4 Goyal K,5 Fakharzadeh S,5 Calabro S,5 Langholff W5
1Stanford Unviersity, Stanford, California, USA.
2Mount Sinai Medical Center, New York, New York, USA.
3 University of British Columbia, Vancouver, British Columbia, Canada
4Dalhousie University, Halifax, Nova Scotia, Canada.
5Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA.

BACKGROUND: PSOLAR is a multicenter, longitudinal, observational study evaluating long-term safety and clinical outcomes for patients eligible to receive treatment for psoriasis with biologics and/or conventional systemic agents.
OBJECTIVE: To report the cumulative incidence of malignancies excluding non-melanoma skin cancers (NMSC) in the PSOLAR study.
METHODS: PSOLAR is a multicenter, longitudinal, observational study evaluating long-term safety and clinical outcomes for patients eligible to receive treatment for psoriasis with biologics and/or conventional systemic agents. The incidence of malignancies excluding NMSC (ie, basal/squamous cell carcinomas) in PSOLAR overall and by treatment groups is reported. Rates of malignancy are assessed using a definition of exposure based on whether patients had ever been exposed to a given therapy at any time prior to the event. In cases of exposure to >1 therapy, the rule for attribution of malignancy to a treatment group is ustekinumab first, infliximab/golimumab second, other biologics third (nearly all adalimumab or etanercept), or non-biologic therapy fourth, which is consistent with the pre-specified analytic plan.
RESULTS: PSOLAR is fully enrolled and as of the August 23, 2013 data cut has 31, 818 cumulative patient-years of follow up with 12,095 patients. Unadjusted cumulative rates of malignancy (excluding NMSC) overall and across treatment groups: overall 0.68 events per 100 patient years of observation (PYO; 95% CI: 0.59, 0.77; 215/31,818), ustekinumab 0.51 per 100 PYO (95% CI: 0.37, 0.68; 45/8,870 PYO), infliximab/golimumab (almost exclusively infliximab) 0.64 per 100 PYO (95% CI: 0.42, 0.93; 27/4,205), other biologics (almost exclusively etanercept/ adalimumab) 0.74 per 100 PYO (95% CI: 0.60, 0.91; 98/13,167), and nonbiologic therapy 0.81 per 100 PYO (95% CI: 0.59, 1.08; 45/5,576). The cumulative rates per 100 PY for the overall registry population for the most frequent specific malignancies were: breast cancer 0.13 (40), prostate cancer 0.09 (30), lung cancer 0.08 (26), and melanoma 0.07 (22).
LIMITATIONS: Rates have not been adjusted for demographic and clinical differences among treatment groups and are subject to attribution rules.
CONCLUSIONS: In the current evaluation, reflecting a median duration of 2.5 years of follow-up, cumulative unadjusted rates of malignancies in PSOLAR are comparable across treatment groups. The most frequently reported malignancies in the registry are comparable with the most frequently reported malignancies in the general population. Additional evaluation of malignancies with accruing longitudinal exposure will be informative.
CORRESPONDING AUTHOR: Steve Fakharzadeh, MD, Janssen Scientific Affairs, LLC, 850 Ridgeview Drive, Horsham, Pennsylvanis 19044. E-mail: [email protected].
DISCLOSURES: Janssen Scientific Affairs, LLC supported the Registry; Fiorentino, Lebwohl, Ho, and Langley are steering committee members of the PSOLAR registry; Goyal, Fahkarzadeh, Calbro, Langholff are employees of Janssen Scientific Affairs, LLC.

PA-36: PASI by body region in a randomized, placebo-controlled trial of adalimumab

Armstrong AW,1 Villanueva-Quintero DG,2 Echeverria CM,3 Gu Y,4 Reyes SO5
1 Department of Dermatology, University of Colorado, Denver, USA
2Dermatológico de Jalisco, Zapopan, JAL, Mexico.
3 Servicio de Dermatología, Hospital Eva Perón, San Martín, Buenos Aires, Argentina.
4AbbVie Inc, North Chicago, Illinois, USA.
5 AbbVie Farmaceuticos S.A. de C.V. PPD, Immunology, Mexico DF, Mexico.

BACKGROUND: Little is known about how psoriasis disease severity or psoriasis treatment effects vary by body region.
OBJECTIVE: We examined whether the efficacy of adalimumab in psoriasis (NCT00237887) differs by body region.
METHODS: A total of 1,212 patients were randomized (2:1) to receive adalimumab 40 mg (after an initial 80-mg dose) or placebo every other week (eow) for 16 weeks. At week 16, mean percent improvement from baseline in regional PASI score and the proportions of patients with ≥75%/90%/100% improvement in regional PASI score (PASI-75/90/100) were calculated.
RESULTS: At baseline, mean regional PASI scores were similar between treatment groups. At week 16, mean percentage improvements in regional PASI score were significantly greater with adalimumab versus placebo for each body region (P < .001); mean percentage improvement with adalimumab was greatest for the trunk (83.1%), followed by the head (81.3%), and upper (75.7%) and lower (73.9%) extremities. Similarly at week 16, regional PASI-75/90/100 response rates were significantly higher with adalimumab versus placebo in all body regions (P < .001); regional PASI-75/90/100 responses were greatest in the trunk (77.6%/64.4%/58.4%), followed by the head (73.8%/65.0%/61.6%), and upper (67.5%/44.8%/39.3%) and lower extremities (65.7%/40.0%/31.2%). Adverse events were typically mild-to-moderate and more frequent with adalimumab than placebo.
CONCLUSIONS: Patients treated with adalimumab 40 mg eow achieved statistically significantly and clinically meaningfully greater improvement in PASI score and higher PASI-75/90/100 response rates in all body regions compared with patients treated with placebo.
CORRESPONDING AUTHOR: April W Armstrong, MD, Department of Dermatology, University of Colorado, 12801 East 17th Avenue, Mail Stop 8127, Aurora, Colorado 80045. E-mail: [email protected].
DISCLOSURES: The authors and AbbVie scientists designed the analysis and/or interpreted the data. All authors contributed to the development of the content; all authors and AbbVie reviewed and approved the presentation; the authors maintained control over the final content. Medical writing support was provided by Jennifer Han, MS, and Michael Theisen, PhD, of Complete Publication Solutions, LLC, Horsham, PA. AbbVie funded the research and medical writing support. April W. Armstrong serves as an investigator and/or consultant for AbbVie, Amgen, Janssen, Merck, Lilly, Celgene, Novartis, Pfizer, and Modernizing Medicine. Delfina G. Villanueva-Quintero has served as a consultant and speaker for AbbVie, Leo Pharma, Pfizer, and UCB Pharma. Cristina M. Echeverría has served as a consultant for AbbVie and UCB Pharma. Yihua Gu and Ofelia Reyes Servin are AbbVie employees and may own AbbVie stock and/ or stock options

PA-37: Penetration of (14C)-efinaconazole topical solution, does not appear to be influenced by nail polish

Zeichner JA,1 Stein-Gold L,2 Korotzer A3
1Mount Sinai School of Medicine, New York, New York, USA.
2 Department of Dermatology, Henry Ford Medical Center, Detroit, Michigan, USA.
3 Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey, USA.

BACKGROUND: Onychomycosis is a common nail disorder with significant medical impacts and aesthetic consequences. Patients seek treatment for several reasons, including unsightliness of their nail(s). Even with successful management, it takes months for the diseased nail to appear cosmetically normal. Patients commonly apply nail polish to mask the appearance of the dystrophic nail, though it is contraindicated with the currently available topical lacquers for onychomycosis.
OBJECTIVES: To compare the in vitro nail absorption of radiolabeled efinaconazole topical solution, through human nails that have been coated with cosmetic nail polish to those without cosmetic nail polish.
METHODS: A human cadaver nail model was used to assess penetration of (14C)-efinaconazole topical solution, 5% through three brands of commonly used nail polish. In addition, a set of uncoated nails was included as the comparator. (14C)-efinaconazole topical solution, 5% (dose determined by weight) was applied on Days 1, 2, 3, 4 and 7; the amount of efinaconazole penetrating into the nail determined by liquid scintillation.
RESULTS: The level of efinaconazole permeating through nails either uncoated, or coated with nail polish was not statistically significantly different at all time points. Permeation of (14C)- efinaconazole through uncoated nails was 0.56% of the applied dose at Day 7, and 0.43%, 0.50%, and 0.51% with the three nail polishes.
CONCLUSION: Nail polish did not appear to inhibit the permeation of efinaconazole under these test conditions. Polishes showed an increase in surface tackiness with repeated efinaconazole topical solution, application. The medical and aesthetic significance of our findings have yet to be assessed clinically.
CORRESPONDING AUTHOR: Joshua A Zeichner, MD, Mount Sinai School of Medicine, 5 East 98th Street, 5th Floor, New York, NY 10029. E-mail: [email protected].
DISCLOSURES: Drs Zeichner and Stein Gold have served as paid consultants to Valeant Pharmaceuticals North America LLC. Dr Korotzer is an employee of Valeant Pharmaceuticals North America LLC.

PA-38: Persistence of biologic therapy in the psoriasis longitudinal assessment and registry (PSOLAR)

Menter A,1 Papp K,2 Krueger GG,3 Augustin M,4 Kerdel F,5 Gooderham M,6 Goyal K,7 Fakharzadeh S,7 Langholff W,7 Sermon J,8 Calabro S,7 Pariser D9
1Baylor University Medical Center, Dallas, Texas, USA.
2Probity Medical Research, Waterloo, Ontario, Canada.
3University of Utah, Salt Lake City, Utah, USA.
4University Clinics of Hamburg, Hamburg, Germany.
5University of Miami, Miami, Florida, USA.
6 SKIN Centre for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada.
7Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA.
8Janssen-Cilag, Beerse, Belgium.
9 Eastern Virginia Medical School and Virginia Clinical Research, Inc, Norfolk, Virginia, USA.

BACKGROUND: PSOLAR, a multicenter, longitudinal, observational study evaluating long-term safety and clinical outcomes for psoriasis (PsO) patients receiving or eligible to receive treatment with biologics and/or conventional systemic agents.
OBJECTIVE: To evaluate persistency (treatment longevity) of biologics for PsO.
METHODS: Duration of exposure was defined as time (in days) between first dose of biologic and the first of: 1) discontinuation 2) switch 3) registry withdrawal or 4) last database cutoff ( August 23, 2013). Separate analyses were performed for: 1st line (bio-naïve; ie, first biologic started on registry), 2nd line (second biologic started while on registry) and 3rd line usage (third biologic started while on registry) to reduce confounding associated with prior exposures. Baseline demographics and reasons for stop/switch were summarized. Persistence was assessed by Kaplan-Meier (KM) analysis for time to therapy stop/switch separately for ustekinumab (UST), infliximab (IFX), adalimumab (ADA), and etanercept (ETN). Cox proportional hazard regression was used to compare time to stop/switch of UST with time to stop/switch of other biologics for each cohort. RESULTS: The highest initiations were attributed to UST (1833) and ADA (1303) with lower for ETN (537) and IFX (327). Among UST starts, the proportions of 1st, 2nd and 3rd line usage were 20%, 31%, and 30%; ADA starts 31%, 48%, and 15%; ETN starts 54%, 29% and 13%; IFX starts 19%, 28% and 32%, respectively. Baseline demographics were generally comparable across biologics and cohorts, with some variability: prevalence of severe PsO was greater for UST and IFX vs ADA and ETN (higher BSA and higher proportions of patients with PGA score of 4 and 5). Fewer patients discontinued UST than IFX, ETN, and ADA, regardless of line of therapy. For first line starts, a better persistence was observed for UST vs the other biologics based on statistically significant differences in time to stop/ switch for each biologic vs UST (IFX vs UST: HR3.04; CI:1.66- 5.57; P = .0003; ADA vs UST: HR4.99; CI:3.39-7.35; P < .0001; ETN vs UST: HR5.59; CI:3.77-8.29; P < .0001). Similar results were observed for analysis of 2nd and 3rd line starts. Median duration of therapy was also generally longer for UST vs the 3 anti-TNF therapies. Reasons for stop/switch were similar across biologics and cohorts (most frequent reason-lack of efficacy).
LIMITATIONS: Data were not adjusted for variability such as socioeconomic factors (eg, access to medication), setting of administration (self vs HCP office), and region.
CONCLUSION: Persistence of ustekinumab therapy in PSOLAR was significantly better than anti-TNF therapies in biologic- naïve and experienced PsO patients, with lower rates of stopping/switching and higher median days on therapy.
CORRESPONDING AUTHOR: Steve Fakharzadeh, MD, Janssen Scientific Affairs, LLC, 850 Ridgeview Drive, Horsham, PA 29044. E-mail: [email protected].
DISCLOSURES: Janssen Scientific Affairs, LLC. supported the registry; Menter, Papp, Krueger, Augustin, Kerdel, Gooderham, Pariser are steering committee members and investigators of the PSOLAR registry; Goyal, Fakharzadeh, Calbro, Langholff are employees of Janssen Scientific Affaris, LLC; J Sermon is an employee of Janssen-Cilag Beerse, Belgium.

PA-39: Pilot study: efficacy and tolerability of a nondrying topical lotion combined with chemical peels in adult female subjects with moderate facial acne and post-inflammatory lesions

Colvan L, Goberdhan LT, Makino ET, Mehta R
SkinMedica, Inc, an Allergan Company, Carlsbad, California, USA.
BACKGROUND: Superficial chemical peels are often used as adjuvants to topical acne treatments as they can provide additional comedolytic effects. However combining chemical peels with these topical treatments can also result in increased side effects including dryness and irritation. Recently a novel topical formulation (acne lotion) was developed containing high levels of antioxidants and anti-inflammatory ingredients to address sebum oxidation/peroxidation and support skin moisturization, as well as salicylic acid (2%) and 4-ethoxybenzaldehyde.
OBJECTIVES: A pilot clinical study was conducted to evaluate the efficacy and tolerability of a regimen including a series of 3 superficial chemical peels (containing lactic acid, salicylic acid, resorcinol and retinol) and the novel acne lotion in subjects with moderate facial acne.
METHODS: A 12-week open-label, single-center pilot study was conducted including eight adult female and male subjects aged 23-37 with moderate facial acne and Fitzpatrick Skin Types II-IV. Subjects received a series of three superficial chemical peels every four weeks and were instructed to apply the acne lotion twice daily (morning and evening) after cleansing. Investigator’s global assessment of acne severity (IGA), acne lesion counts, post-inflammatory hyperpigmentation or erythema (PIH/PIE) and tolerability assessments (erythema, burning/ stinging, dryness/scaling and itching) were conducted at baseline and weeks 4, 8 and 12. Standardized digital photography was taken at all visits and a self-assessment questionnaire was performed at weeks 4, 8, and 12.
RESULTS: The regimen provided significant reductions in mean scores for IGA at weeks 4, 8 and 12 (all P < .04). Significant reductions were also observed for PIH/PIE at all visits (all, P < .005). Both inflammatory and non-inflammatory lesion counts consistently decreased at all follow-up visits, resulting in mean percent changes of -41.3% and -30.7% at week 12, respectively. The chemical peel and acne lotion regimen was very well-tolerated with mean tolerability scores remaining below mild throughout the study duration. Results from the subject self-assessment questionnaire and standardized photographs support the significant improvements in efficacy observed by the investigator.
LIMITATIONS: The small study size is a key limitation for this clinical study.
CONCLUSIONS: This pilot study suggests that the combination of new acne lotion with a series of chemical peels may provide a well-tolerated solution for adult patients seeking an effective treatment for moderate facial acne as well as postinflammatory hyperpigmentation and/or erythema.
CORRESPONDING AUTHOR: Elizabeth Makino, SkinMedica, Inc, an Allergan Company, 2525 DuPont Drive, MI3-450C, Irvine, CA 92623.
DISCLOSURES: The authors are employees of SkinMedica, Inc, an Allergan Company, the sponsor for the clinical study. Ms. Colvan reports other from SkinMedica, Inc, an Allergan Company, during the conduct of the study; other from Skin- Medica, Inc, an Allergan Company, outside the submitted work. Ms Goberdhan, Ms Makino, and Dr Mehta report other from SkinMedica, Inc, an Allergan Company, during the conduct of the study; other from SkinMedica, Inc, an Allergan Company, outside the submitted work.
FUNDING/SUPPORT: All funding of the clinical study was provided by the sponsor, SkinMedica, Inc, an Allergan Company.

PA-40: Punch-grafting for treatment of chronic leg and foot ulcers: a retrospective chart study

Sönnergren HH, Polesie S, Faergemann J
Department of Dermatology and Venereology, The Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
BACKGROUND: Punch-grafting treatment is a treatment method where autologous split-skin dermal punch-biopsies are grafted to an ulcer.
OBJECTIVE: The aim was to assess the healing and adverse events rates of punch-grafting for the treatment of hard to heal foot and leg ulcers.
METHODS: The study was a single centre retrospective chart study. The punch-graft-group consisted of a consecutive series of all patients that had undergone punch-graft-treatment for one or several foot or leg ulcers at the Department of Dermatology, Sahlgrenska University Hospital, during year’s 2009-2013.
RESULTS: Ninety-two patients with 119 ulcers with a mean duration of 28.8 months had undergone punch-grafting. The cases were 59.8% female with a mean age of 72.9 ± 11.7 years. 6.7% were foot ulcers and 93.3% leg ulcers. 42.9% were venous ulcers 8.4% arterial ulcers, 26.1% mixed arterial/venous ulcers, and 22.7% had other aetiologies. Complete healing had been reached for 16.8% at 3 months and 50.5% at 12 months with a mean healing time of 148 days. At both 3 and 12 months arterial ulcers had a higher healing rate than venous ulcers. Adverse events recorded consisted of 12 patients with ulcer infection, and one patient who got a hard to heal ulcer at the donor site.
LIMITATIONS: The study limitations are that the study is retrospective and and does not compare the results of punchgrafting to a control group.
CONCLUSION: This retrospective study indicates that punchgrafting treatment may be a beneficial treatment in chronic ulcers with long duration where standard treatment methods have failed. The method may support healing and has a low adverse events rate. The method should be further evaluated in prospective randomized controlled trials.
CORRESPONDING AUTHOR: Henrik H. Sönnergren, MD, Department of Dermatology and Venereology, The Sahlgrenska Academy, University of Gothenburg and Sahlgrenska University Hospital, Gröna stråket 16, Gothenburg, Sweden SE-41303. Email: [email protected].
DISCLOSURES: The authors have no disclosures.

PA-41: Safety and efficacy of calcipotriene plus betamethasone dipropionate topical suspension in adolescents with scalp psosriasis: an open, non-controlled, 8-week trial

Gooderham M,1 Xu Z,2 Kurvits M2
1Skin Centre for Dermatology, Ontario, Canada.
2LEO Pharma A/S, Ballerup, Denmark.

BACKGROUND: Efficacy and safety of calcipotriene plus betamethasone dipropionate topical suspension (Cal/BD), in plaque psoriasis on body and scalp has been shown in adult patients, but the experience from treatment of adolescents is limited.
OBJECTIVE: The second of two parallel, independent studies to investigate the safety and efficacy of C/BD topical suspension applied once daily for up to 8 weeks in adolescents with scalp psoriasis.
METHODS: This was a prospective, noncontrolled, multicenter trial conducted in Canada, France and the United Kingdom. Patients aged 12–17 years with moderate-to-severe scalp psoriasis affecting at least 10% of the scalp area were included. Safety was the primary objective and was assessed in terms of adverse drug reactions and change from baseline in serum and urinary calcium. Efficacy assessments included Investigator’s Global Assessment (IGA), Total Sign Score (TSS; sum of scores for redness, thickness and scaliness), Patient’s Global Assessment (PaGA), and Patient’s Assessment of Itching.
RESULTS: In total, 78 subjects (35 boys and 43 girls) with a median age of 15 years were enrolled and assigned treatment. Mean extent of psoriasis was 43.7% of the scalp area, and 74.4% and 25.6% of subjects had moderate and severe/very severe scalp psoriasis, respectively. A mean weekly amount of 36.0 g of topical suspension was applied. Five subjects reported adverse drug reactions and there were no serious adverse events. No cases of hypercalcemia were reported and there were no clinically relevant changes in urinary calcium. At the end of treatment, 84.6% were clear or almost clear according to the IGA. The mean percentage improvement in TSS from baseline to end of treatment was 80.4%. At end of treatment, 87.2% rated their scalp psoriasis as clear or very mild on the PaGA scale and 96.2% had no or mild itching compared to 17.9% at baseline.
LIMITATIONS: Treatment of psoriasis of the body was not investigated in this study.
CONCLUSIONS: In this open trial, C/BD topical suspension was well tolerated with no effect on calcium metabolism in adolescents with scalp psoriasis. The product appeared to be efficacious as rated by investigators and subjects, including a clinically relevant improvement of itching.
CORRESPONDING AUTHOR: Melinda Gooderham, Skin Centre for Dermatology, 743 Lansdowne Street West, Peterborough, Ontario, Canada K9J 1Z2. Email: mjgooderham @gmail.com.
DISCLOSURES: Dr Gooderham reports other from Celgene Corporation, during the conduct of the study; personal fees and other from AbbVie Pharmaceuticals, personal fees from Actelion Pharmaceuticals Ltd, other from Accord Healthcare, personal fees and other from Amgen, personal fees from Astellas, other from Dermira, other from Dr Reddy’s Laboratories, personal fees and other from Galderma Laboratories, personal fees from Graceway, personal fees from Janssen Pharmaceutical, other from Kythera, other from Kyowa Hakko Kirin Pharma, personal fees and other from LEO Pharma, other from Lilly, other from Novartis, other from Pfizer Inc, other from Forward- Pharma, outside the submitted work. Dr Xu reports that they are an employee of LEO Pharmaceuticals. Ms Kurvits reports that she is an employee of LEO Pharmaceuticals.

PA-42: Superior efficacy of the fixed combination calcipotriene plus betamethasone dipropionate in an innovative aerosol foam versus ointment, in patients with psoriasis vulgaris

Koo J,1 Tyring S,2 Werschler WP,3 Bruce S,4 Olesen M,5 Villumsen J,5 Bagel J6
1University of California, San Francisco, USA.
2University of Texas Health Science Center, Houston USA.
3University of Washington School of Medicine, Seattle, USA.
4Suzanne Bruce and Associates, PA, Houston, Texas, USA.
5LEO Pharma A/S, Ballerup, Denmark.
6 Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA .

BACKGROUND: An innovative aerosol foam formulation of the fixed combination calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) has been developed to improve treatment for patients with psoriasis.
OBJECTIVE: To compare the efficacy and safety of this aerosol foam formulation with the Cal/BD ointment (Taclonex®), a first-line treatment for psoriasis vulgaris. METHODS: In this Phase 2, multicenter, investigator-blind, vehicle-controlled, 4-week trial, patients aged ≥18 years with mild-to-severe psoriasis of the body were randomized 3:3:1:1 to the following treatments: Cal/BD foam, Cal/BD ointment, foam vehicle, or ointment vehicle (NCT01536886). For each active treatment arm, a corresponding vehicle control was included in order to blind the patients and investigators to treatment; statistical comparisons with vehicle treatments were not performed. The primary efficacy endpoint was the proportion of patients who were ‘clear’ or ‘almost clear’ (for patients with at least moderate disease at baseline), or ‘clear’ (for patients with mild disease at baseline) at Week 4, according to the Physician’s Global Assessment (PGA); this was defined as ‘controlled disease’. Secondary endpoints included modified Psoriasis Area Severity Index (mPASI; excluding the head, which was not treated) scores at Weeks 1 and 4, the proportion of patients achieving 50% or 75% reductions in mPASI (PASI-50 or PASI-75) at Week 4, and patient’s assessment of itch (by visual analogue scale). Safety was monitored throughout. RESULTS: In total, 376 patients (median age 51 years [range 21–88]) were randomized to Cal/BD foam (n = 141), Cal/BD ointment (n=135), foam vehicle (n = 49) or ointment vehicle (n = 51). The completion rate was >94% in all treatment groups; missing data were handled by last observation carried forward. At Week 4, a significantly larger proportion of Cal/BD foam-treated patients achieved ‘controlled disease’ versus Cal/BD ointment-treated patients (54.6% [n = 77] vs 43.0% [n = 58]; OR 1.7, 95% CI 1.1, 2.8; P = .025). The mean mPASI score was significantly lower for Cal/BD foam and Cal/ BD ointment at Week 1 (difference –0.7; 95% CI –1.1, –0.3; P = .001) and Week 4 (difference –0.6; 95% CI –1.1, –0.2; P = .005). Mean mPASI score was 7.0 (baseline), 3.95 (Week 1) and 1.82 (Week 4) with Cal/BD foam versus 6.7, 4.64 and 2.46 with Cal/BD ointment, respectively. At Week 4, greater proportions of patients in the Cal/BD foam group achieved PASI-50 or PASI-75 than in the ointment group (PASI-50, 81% vs 75%; PASI-75, 50% vs 41%). With both active treatments, similar rapid and continuous itch relief was achieved. Six adverse drug reactions were reported: application-site pruritus (n = 1, Cal/BD foam); application-site dryness, application-site pain, and psoriasis (each n=1, Cal/BD ointment); pruritus (n = 2, Cal/BD ointment). Two patients (both in the Cal/BD ointment group) experienced three serious AEs (bile duct stone, bronchitis, hypertension); all were considered not related to treatment. The mean values of albumin-corrected serum calcium and urinary calcium:creatinine ratio were similar across the treatment groups and were within the normal range (2.15–2.55 mmol/L), both at baseline and Week 4.
LIMITATIONS: Treatment of scalp psoriasis was not investigated in this comparative study.
CONCLUSIONS: This study reported greater efficacy and similar tolerability in patients treating psoriasis vulgaris with the innovative Cal/BD aerosol foam formulation compared with patients using Cal/BD ointment.
DISCLOSURES: This study reported greater efficacy and similar tolerability in patients treating psoriasis vulgaris with the innovative Cal/BD aerosol foam formulation compared with patients using Cal/BD ointment. Dr Koo reports personal fees from AbbVie, personal fees from LEO Pharmaceuticals, grants from Amgen, grants from Janssen, grants from Novartis Pharmaceuticals Corp, grants from Photomedex, grants from Galderma, grants from Merck, grants from Pfizer, outside the submitted work. Dr Tyring reports grants from LEO Pharmaceuticals, outside the submitted work. Dr Werschler reports grants and personal fees from LEO Pharmaceuticals, outside the submitted work. Dr Bruce reports personal fees from LEO Pharmaceuticals , grants from Actavis Inc, grants and personal fees from Allergan, grants from Anacor, grants from DUSA, grants from Galderma R&D Inc, grants from Novartis Pharmaceuticals Corporation, grants from Obagi Medical Products Inc, grants from Pfizer, grants from Stiefel Laboratories Inc, grants from Suneva, grants from Taro, grants from Tolmar Inc, grants from HealthOutcome Solutions, grants from AbGenomics, grants from Revance, grants and personal fees from Lithera, grants from Braintree, grants from Maruho Co ltd, grants from Tigercat Industries Inc, grants from G&E Herbal Biotechnology Company, grants from Promius Pharma, grants from Watson Pharmaceuticals, personal fees from Lumenis, grants from Cipher Pharmaceuticals, personal fees from Ulthera, grants from G&W Laboratories, grants from Ranbaxy Laboratories, outside the submitted work. Dr Olesen reports that he was an employee of LEO Pharmaceuticals at the time of the study. Dr Villumsen reports that he is an employee of LEO Pharmaceuticals. Dr Bagel reports grants and personal fees from LEO Pharmaceuticals , grants and personal fees from Abbvie, grants and personal fees from Janssen, grants and personal fees from Novartis Pharmaceuticals Corp, grants and personal fees from Lilly, grants and personal fees from Celgene, personal fees from Amgen, grants from Boehringer, outside the submitted work.

PA-43: The efficacy and tolerability of a fixed combination clindamycin (1.2%) and benzoyl peroxide (3.75%) aqueous gel in patients with facial acne vulgaris: gender as a clinically relevant outcome variable

Harper JC
The Dermatology and Skin Care Center of Birmingham, Alabama, USA.
BACKGROUND: There has been increased interest in possible gender differences when it comes to acne treatment, with limited evidence suggesting gender-difference response to specific treatments.
OBJECTIVE: To investigate whether treatment differences exist in male and female patients with moderate-to-severe acne treated with clindamycin phosphate 1.2%/BP 3.75% gel or vehicle as monotherapy.
METHODS: A post hoc analysis comparing the efficacy and cutaneous tolerability in 498 male and female patients with moderate-to-severe acne receiving clindamycin phosphate 1.2%/BP 3.75% gel, or vehicle for 12 weeks.
RESULTS: The efficacy of clindamycin phosphate 1.2%/BP 3.75% gel was greater than vehicle (P > .001) in both genders. Within the clindamycin phosphate 1.2%/BP 3.75% gel group, the mean percent change from baseline in inflammatory and noninflammatory lesion counts was greater among females than males, as was the percentage of subjects who achieved a 2-grade reduction in the EGSS (P = .049).
LIMITATIONS: It is not possible to determine the contributions of the individual active ingredients.
CONCLUSIONS: Clindamycin phosphate 1.2%/BP 3.75% gel provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile. It appears to be more effective in female patients.
CORRESPONDING AUTHOR: Julie C Harper, MD, Dermatology and Skin Care Center of Birmingham, Birmingham, AL 35243. E-mail: [email protected].
DISCLOSURES: Dr Harper has served as paid consultant to Valeant Phamaceuticals North America LLC.

PA-44: The efficacy and tolerability of a fixed combination of clindamycin (1.2%) and benzoyl peroxide (3.75%) aqueous gel in adult females with facial acne vulgaris

Zeichner JA
Mount Sinai School of Medicine, New York, New York, USA.
BACKGROUND: An increasing number of older women seek acne treatment from dermatologists. However, data on the treatment of acne in the adult female population is limited.
OBJECTIVE: To investigate the efficacy and tolerability of clindamycin phosphate 1.2%/BP 3.75% gel or vehicle monotherapy in adult female acne patients.
METHODS: A post hoc analysis in 72 adult female patients (aged ≥25 years) with moderate-to-severe acne receiving clindamycin phosphate 1.2%/BP 3.75% gel, or vehicle for 12 weeks.
RESULTS: The efficacy of clindamycin phosphate 1.2%/BP 3.75% gel was significantly greater than vehicle. The mean percent change from baseline in inflammatory and noninflammatory lesion counts and the percentage of patients who achieved a 2-grade reduction in the EGSS was 68.7%, 60.4% and 52.7% respectively (P = .019, .020 and .074 vs vehicle). In addition, 44.0% of patients reported their acne to be ‘clear’ or ‘almost clear’ at week 12 (P = .026 vs vehicle). No substantive differences were seen in cutaneous tolerability among treatment groups and no patients discontinued treatment because of adverse events.
LIMITATIONS: It is not possible to determine the contributions of the individual active ingredients and this study was not set up specifically to investigate the treatment of adult female acne.
CONCLUSION: Clindamycin phosphate 1.2%/BP 3.75% gel provides statistically significant greater efficacy than vehicle in treating adult female acne with a favorable safety and tolerability profile.
CORRESPONDING AUTHOR: Joshua A Zeichner, MD, Mount Sinai School of Medicine, 5 East 98th Street, 5th Floor, New York, NY 10029. E-mail: [email protected].
DISCLOSURES: Dr Zeichner has served as a paid consultant to Valeant Pharmaceuticals North America LLC.

PA-45: Treatment of onychomycosis with efinaconazole topical solution, 10% and quality of life

Tosti A,1 Elewski BE2
1 Department of Dermatology & Cutaneous Surgery Leonard Miller School of Medicine University of Miami, Florida, USA. 2 Department of Dermatology, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.
BACKGROUND: Onychomycosis can have a significant impact on quality of life (QoL), disrupting daily activities and occasionally results in significant pain and discomfort. There is a lack of data to demonstrate the true QoL response to effective onychomycosis treatment.
OBJECTIVE: To evaluate the benefits of efinaconazole topical solution, 10% on QoL in onychomycosis patients.
METHODS: An analysis of 1655 patients, aged 18-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from two identical multicenter, double-blind, vehiclecontrolled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture); clinical improvement defined as ≤10% improvement in nail involvement both at week 52. QoL was assessed using a validated OnyCOE-t questionnaire. Improvement in QoL was compared in those patients clinically and not clinically improved.
RESULTS: Efinaconazole topical solution, 10% was significantly more effective than vehicle irrespective of QoL domain. Greatest improvement in mean score was seen in those domains with the lowest baseline scores. All mean scores in the group considered to have clinically improved with efinaconazole exceeded 80.0 at week 52. Mean treatment satisfaction scores with efinaconazole in those patients who were clinically improved increased from 79.9 (week 24) to 89.2 (week 52), compared to a corresponding drop in those patients considered not improved from 65.3 to 58.0. The correlation between change in % affected nail and change in mean domain scores was significant with efinaconazole for all domains.
LIMITATIONS: A period of 52 weeks may be too brief to evaluate improvement in QoL in onychomycosis patients. Some of the questions in the OnyCOE-t questionnaire may be more relevant than others to the study population and the onychomycosis population as a whole.
CONCLUSIONS: Once daily efinaconazole topical solution, 10% provided statistically greater improvement in all aspects of QoL compared to vehicle. Improvement was most marked in those patients considered clinically improved and correlated with a change in percent affected nail.
CORRESPONDING AUTHOR: Antonella Tosti, MD, Department of Dermatology & Cutaneous Surgery Leonard Miller School of Medicine University of Miami, FL 33136. E-mail: [email protected].
DISCLOSURES: Drs Tosti and Elewski have served as paid consultants to Valeant Pharmaceuticals North America, LLC. They were investigators in the study.