Journal of Clinical and Aesthetic Dermatology

MauiDerm Abstract Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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[ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] S U P P L E M E N T T O T H E J O U R N A L O F C L I N I C A L A N D A E S T H E T I C D E R M AT O L O G Y S11 b ody surface area (BSA) were enrolled in two multicenter, double-blind, vehicle-controlled studies of identical design. Patients were randomized 2:1 to receive crisaborole or vehicle twice d aily for 28 days and were evaluated on Days 8, 15, 22, and 29. The primary endpoint defined success in the Investigator's Static Global Assessment (ISGA) as "clear/0"or "almost clear/1" w ith ≥2-grade improvement from baseline at Day 29. Secondary endpoints measured the percentage of patients achieving "clear/0" or "almost clear/1" on ISGA and time to success in ISGA goal. Results: Studies 1 and 2 enrolled 503:256 and 513:250 crisaborole/vehicle patients, respectively. There were no significant differences in key baseline characteristics across all groups/studies (pooled data: mean age ~12 years, mean BSA ~18%, ISGA ~60% "moderate/3" and ~40% "mild/2"). More patients achieved success in ISGA with crisaborole than vehicle at Day 29 (Study 1: 32.8% vs. 25.4%, P=0.038; Study 2: 31.4% vs. 18.0%, P<0.001), with a greater percentage of "clear/0" or "almost clear/1" ISGA scores (51.7% vs. 40.6%, P=0.005; 48.5% vs. 29.7%, P<0.001). Patients achieved success in ISGA goals earlier when treated with crisaborole than vehicle (P<0.001). Treatment-related adverse events (AEs) were mostly mild and included application site pain (pooled data, crisaborole vs. vehicle: 4.4% vs. 1.2%) and upper respiratory tract infection (3.0% vs. 3.0%). Discontinuation rates due to AEs were 1.2% for both crisaborole and vehicle. Conclusion: Crisaborole Topical Ointment, 2%, demonstrated favorable efficacy and safety in two large Phase 3 studies and may represent a safe and efficacious treatment for patients as young as two years with mild-to- moderate AD. ONYCHOMYCOSIS An In Vitro Study Demonstrating Nail Penetration of Tavaborole from Tavaborole Topical Solution, 5% through Multiple Layers of Nail Polish P resenters: 1 B oni E. Elewski; 2 D ina Coronado; 2 Sanjay Chanda; 2 Tejal Merchant; 2 Huiming Lin; 2 Lee T. Zane; 3 Tracey Vlahovic Affiliations: 1 Department of D ermatology, University of Alabama, Birmingham, AL; 2 Anacor Pharmaceuticals, Inc., Palo Alto, CA; 3 Temple University School of Podiatric Medicine, Philadelphia, PA I ntroduction: Onychomycosis is a common infection of the fingernails and toenails resulting in thickening, discoloration, and deformity of the nail plate. Onychomycosis may have a significant psychological impact on individuals affected by this condition. Tavaborole Topical Solution, 5% (tavaborole, Anacor Pharmaceuticals, Inc., Palo Alto, CA) is a novel, boron- based pharmaceutical approved by the US FDA in July 2014 for the treatment of toenail onychomycosis caused by Trichophyton rubrum and T. mentagrophytes. • It is a highly specific protein synthesis inhibitor that targets fungal cytoplasmic leucyl-tRNA synthetase (LeuRS), an aminoacyl- tRNA synthetase. These enzymes play a pivotal role in maintaining and translating the genetic code within DNA. • Tavaborole binds to the active editing site and traps tRNA, preventing catalytic turnover and synthesis of leucine-charged tRNAs. In this way, tavaborole inhibits cellular protein synthesis and suppresses fungal activity. • Tavaborole retains its pharmacologic activity in the presence of keratin remaining in the nail plate for at least three months after dosing. Objective: The objective of this study was to evaluate the nail penetration properties of Tavaborole Topical Solution, 5% through multiple layers of nail polish. Methods: Human cadaver fingernails from eight female donors were mounted on Vertical Diffusion Cells and randomized to four groups representing different nail polish application practices (for each, N=7); Tavaborole Topical Solution, 5% was applied daily (25µL/cm 2 ) to each nail f or 14 days. Group 1: 4 coats of Salon Typical (1 base coat, 2 coats of polish, 1 clear coat) Group 2: 1 coat of a Salon Typical G roup 3: 2 coats of a Home Typical Group 4: 1 coat of a Home Typical Unpainted reference control. Results: Mean (standard deviation) cumulative penetration of tavaborole f rom Tavaborole Topical Solution, 5% through nails after 14 days of dosing: Group 1: 1178.53 (554.40) Group 2: 1227.30 (974.00) Group 3: 1492.52 (1322.09) Group 4: 1428.19 (840.82) Unpainted nails: 565.91. Nail penetration was measured by monitoring the rate of drug appearance each day in the receiving medium. Approximately 24 hours after each dose, the receiving medium from each cell was removed and replaced with fresh solution. Prior to each subsequent daily dose, the nails were cleaned with a cotton swab moistened with water. Aliquots of each receiving medium sample were analyzed using high performance liquid chromatography. Conclusion: Tavaborole Topical Solution, 5% can penetrate through up to four layers of nail polish. PSORIASIS Efficacy and Safety of Adalimumab versus Methotrexate Treatment in Pediatric Patients with Severe Chronic Plaque Psoriasis: Results from the 16- Week Randomized, Double-Blind Period of a Phase 3 Study Presenters: 1 Kim Papp, MD; 2 Diamant Thaci, MD2; 3 Danielle Marcoux, MD; 4 Lisa Weibel, MD; 5 Kristina Unnebrink, PhD; 6 David A Williams, MD Affiliations: 1 Probity Medical Research, University of Western Ontario, Waterloo, ON, Canada; 2 Comprehensive Center for Inflammation Medicine, University Medical School Schleswig Holstein, Campus Lübeck, Germany; 3 CHU Sainte-Justine Montreal, Quebec, Canada; Montreal, QC, Canada; 4 Pediatric Dermatology Department, S 1 1

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