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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S7 JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) ACNE Olumacostat Glasaretil (DRM01) for the Treatment of Acne Vulgaris: Primary Results from the DRM01- ACN02 Phase 2b Randomized Controlled Trial Presenters: James Q. Del Rosso, 1 Linda F. Stein Gold, 2 Leon Kircik, 3 Jerry Tan, 4 Catherine Maari, 5 Robert Bissonnette, 5 Hans Hofland, 6 Janice Drew, 6 Beth Zib, 6 John Quiring, 7 Guy Webster 8 Affiliations: 1 Touro University Nevada, Henderson, NV; 2 Henry Ford Hospital, Detroit, MI; 3 DermResearch, Louisville, KY; 4 Western University, London, Ontario, Canada; 5 Innovaderm Research Inc., Montréal, Québec, Canada; 6 Dermira, Inc., Menlo Park, CA; 7 QST Consultations, Allendale, MI; 8 Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA Objective: Sebum production, a critical factor in acne pathophysiology, is not addressed by available topical therapies. Olumacostat glasaretil inhibits acetyl coenzyme-A carboxylase, the enzyme that regulates the synthesis of fatty acids, a major component of sebum lipids. This phase 2b trial assessed the safety and efficacy of olumacostat glasaretil gel in patients with facial acne vulgaris. Methods: DRM01-ACN02 (NCT02431052) was a randomized, double-blind, vehicle-controlled, dose- ranging, 12-week trial. Eligible patients were adults with facial acne vulgaris, defined as ≥20 inflammatory acne lesions (IALs), ≥20 non-inflammatory acne lesions (NIALs), and an Investigator Global Assessment (IGA) score of 3 or 4. Patients were randomized 1:1:2:2:2 to receive vehicle once daily (VH-QD); vehicle twice daily (VH-BID); or olumacostat glasaretil 4% QD, 7.5% QD, or 7.5% BID. Primary endpoints assessed response to olumacostat glasaretil through IAL and NIAL counts, and IGA response rates (≥2-point improvement from baseline) at Week 12. Missing values in the ITT population were imputed using MCMC multiple imputation. Significance calculations were performed versus combined vehicle group using ANCOVA model (IAL, NIAL count) and Cochran-Mantel-Haenszel test (IGA response). Results: 420 patients were randomized to receive VH-QD; VH- BID; or olumacostat glasaretil 4% QD, 7.5% QD, or 7.5% BID. Baseline characteristics were similar between patients across treatment arms. Least- squares mean reduction in absolute IAL and NIAL counts from baseline to Abstracts of Poster Presentations: MauiDerm 2017 March 20–24, 2017 • Grand Wailea • Maui, Hawaii The 2017 edition of the annual MauiDerm meeting had a wide variety of clinical and scientific data presented not only at the podium, but in its poster sessions as well. A wide range of clinically relevant material was presented in poster format. For those of you who were not on hand to review the posters and discuss them with their authors, we have compiled and indexed selected posters from the 2017 meeting. It is my hope that you will find the posters informative and thought provoking. For an alphabetical index organized by poster title or author, please see page 30 of this supplement. George Martin, MD Program Director, MauiDerm; Dermatology Laser Center Maui Kihei, Hawaii VOL. 10, NO. 5 (SUPPLEMENT 1) • MAY 2017 • JCADONLINE.COM

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