Journal of Clinical and Aesthetic Dermatology

MauiDerm 2017

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

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S13 JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) a ging skin with twice-daily, targeted t reatment over eight weeks. Methods: A prospective, open-label study was conducted in 25 females, 30 to 65 years of age with moderate photoaging in ≥1 of the following areas: fine lines/wrinkles, crow's feet, forehead wrinkles, and nasolabial folds. S ubjects applied study product twice daily to identical targeted areas only. Expert-graded evaluations were based on digital photography using Canfield VISIA-CR at baseline, 4, and 8 weeks. A subset of subjects (n=5) applied study product twice daily to spots on their forearm delineated by small temporary tattoos for ultrasound measurements at each time point. Additionally, subjects completed a self-assessment questionnaire at baseline, 2, 4, and 8 weeks. Tolerability was assessed throughout the study. Results: Twenty-five subjects completed the study. Expert-grader evaluations demonstrated 31, 23, and 21 percent average reductions from baseline in crow's feet, forehead lines, and fine lines/wrinkles at eight weeks. Additionally, 68 percent of subjects demonstrated improvement in nasolabial folds from baseline at eight weeks. Ultrasound images demonstrated increased skin thickness and density from baseline measurements at Week 8. Nearly 90 percent of subjects reported agreement in reductions in the appearance of fine lines/wrinkles, and improvements in skin smoothness and softness; 72 percent of subjects reported that they looked younger. Five subjects reported mild adverse events; one mild breakout may have been related to study product. No subject discontinued treatment. Conclusion: Twice-daily treatment with a large molecule, injectable-grade HA-containing cream demonstrated r eductions in the appearance of crow's f eet, forehead lines, and fine lines/wrinkles, and improvement in nasolabial folds in the majority of subjects. Additionally, high subject satisfaction was achieved in improvement in the appearance of fine lines/wrinkles. The injectable-grade HA c ream was highly tolerated throughout the study period. PSORIASIS Improvements in Lesional Burning and Stinging With Brodalumab in Psoriasis Studies Presenters: Lawrence Green, 1 Leon Kircik, 2,3 David M. Pariser, 4,5 Shipra Rastogi, 6 Radhakrishnan Pillai, 7 Robert J. Israel 6 Affiliations: 1 George Washington University School of Medicine, Washington, DC; 2 Indiana University School of Medicine, Indianapolis, IN; 3 Mount Sinai Medical Center, New York, NY; 4 Eastern Virginia Medical School, Norfolk, VA; 5 Virginia Clinical Research, Inc, Norfolk, VA, USA; 6 Valeant Pharmaceuticals North America LLC, Bridgewater, NJ; 7 Dow Pharmaceutical Sciences (a division of Valeant Pharmaceuticals North America LLC), Petaluma, CA Background: Brodalumab is an interleukin-17RA antagonist with high skin clearance efficacy in psoriasis. The efficacy and safety of brodalumab in three Phase 3, multicenter, randomized, double-blind, placebo- and active comparator–controlled studies in patients with moderate-to-severe psoriasis (AMAGINE-1/-2/-3) have been previously evaluated and reported. This analysis evaluated the effect of brodalumab on lesional burning and stinging, as assessed by the psoriasis symptom inventory (PSI), a validated patient-reported outcome instrument f or use in patients with moderate-to- s evere psoriasis. Burning and stinging sensations are distinct from lesional pain and can contribute to diminished quality of life. Methods: Patients were randomized to receive brodalumab (140 or 210mg Q2W) or placebo and/or ustekinumab d uring the 12-week induction phase. Patients used a daily electronic diary to rate the severity of symptoms during the previous 24 hours on a PSI scale of 0 (not at all severe) to 4 (very severe). In addition to visual assessments of redness, scaling, cracking, and flaking symptoms, which were also included in PASI and sPGA investigator evaluations, the PSI assessed itch, burning, stinging, and pain symptoms. Daily assessments of burning and stinging symptoms were analyzed as weekly PSI averages. At each study visit (including the baseline assessment), patients determined to be PSI responders reported an average weekly score ≤1. Results: Baseline mean PSI weekly averages for burning and stinging, respectively, were 2.1 and 2.1 for the placebo group; 2.1 and 2.0 for the brodalumab 140mg group; and 2.1 and 2.0 for the brodalumab 210mg group. Mean scores were significantly lower with both doses of brodalumab relative to placebo for both endpoints by Week 2, and remained significantly decreased through Week 12 (P<0.001). At baseline, the percentages of patients with average weekly PSI scores ≤1 (responders) for burning and stinging were 17.4 and 20.9 percent for the placebo group (n=844); 18.9 and 21.0 percent for the brodalumab 140mg group (n=1458); and 18.3 and 20.6 percent for the brodalumab 210mg group (n=1458), respectively. By Week 2, the percentages of responders for burning and stinging had significantly

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