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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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 [ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] 5 J oan-En Chang-Lin, PhD; 5 D avid Berk, MD; 5 Shiling Ruan, PhD; 5 Alexandre Kaoukhov, MD Affiliations: 1 University of California, San Diego and Rady Children's H ospital, San Diego, CA; 2 P rivate Practice, Austin, TX; 3 RISkinDoc, Cranston, RI; 4 Dermatologe, Bryan, TX; 5 Allergan plc, Irvine, CA Purpose: Acne treatment with d apsone gel 5% requires twice-daily dosing. This second of two studies assessed efficacy and safety of a new once-daily formulation of dapsone gel 7.5% (DAP) versus vehicle (VEH) over 12 weeks in patients with moderate acne. Methods: This randomized, double- blind, multicenter study enrolled 2,238 patients (≥12y) with 20 to 50 inflammatory lesions, 30 to 100 noninflammatory lesions, and a moderate grade (3) on the Global Acne Assessment Score (GAAS). Investigator-assessed efficacy measures at Week 12 were GAAS success rate (GAAS=0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions. Results: At Week 12, for DAP versus VEH, respectively, GAAS success rate was 29.8 percent versus 20.9 percent mean inflammatory lesions decreased by 53.8 percent versus 47.3 percent, mean noninflammatory lesions decreased by 45.9 percent versus 40.4 percent and mean total lesions decreased by 48.9 percent versus 43.2 percent (all P<0.001). AE incidence was 17.6 percent for DAP and 17.1 percent for VEH. Most AEs in both groups were mild to moderate in severity. Most patients receiving DAP and VEH had a severity rating of "none" for stinging/burning, dryness, scaling, and erythema scales at all time points. Conclusion: Dapsone gel 7.5% applied topically once daily is an effective, safe, and well-tolerated topical acne treatment. Age and Gender as Predictors of Treatment Outcomes with Once- Daily Dapsone 7.5% Topical Gel for Acne Vulgaris Presenters: 1 Zoe Diana Draelos, MD; 2 David A. Rodriguez, MD; 3 Steven E . Kempers, MD; 4 S uzanne Bruce, MD; 5 Marina I. Peredo, MD, PC; 6 Jeanine Downie, MD; 7 Joan-En Chang-Lin, PhD; 7 David R. Berk, MD; 7 Shiling Ruan, PhD; 7 Alexandre Kaoukhov, MD A ffiliations: 1 D ermatology Consulting Services, High Point, NC; 2 Dermatology Associates and Research, Coral Gables, FL; 3 Associated Skin Care Specialists, F ridley, MN; 4 S uzanne Bruce and Associates, PA, Houston, TX; 5 Private Practice, Smithtown, NY; 6 Image Dermatology, Montclair, NJ; 7 Allergan, Inc., Irvine, CA Introduction: A new, once-daily topical dapsone gel 7.5% (DAP) was developed to simplify topical anti- inflammatory acne treatment relative to twice-daily Aczone ® Gel 5%. Pooled data from two identical Phase 3 randomized, double-blind, vehicle (VEH)-controlled trials of DAP for acne assessed the effects of age, gender, and race on treatment outcomes. Methods: Patients with moderate acne (20–50 inflammatory lesions, 30– 100 noninflammatory lesions, and Global Acne Assessment Score [GAAS] of 3) were randomized to once-daily treatment for 12 weeks with DAP or VEH. Co-primary efficacy measures were GAAS responder rates (GAAS- RR; no or minimal lesions at Week 12) and changes in inflammatory and noninflammatory lesions. In the pooled analysis, efficacy variables were analyzed by age group (12–17y [adolescents] and ≥18y [adults]), gender, and race (Caucasian and non- Caucasian). Results: Overall, the intent-to-treat analysis included 4,340 patients (DAP, n=2,162; VEH, n=2,178); 50.5% were adults, 55.8% were female, and 57.4% were Caucasian. At baseline, all but one had a GAAS of 3; mean inflammatory and noninflammatory lesion count was 29.4 and 47.2, respectively. Significant improvements (P<0.001) for DAP versus VEH on co- primary outcomes were observed at Week 12. GAAS-RR was significantly greater (P<0.001) for DAP (29.8%) versus VEH (21.1%). Significantly greater (P<0.001) percent reductions for DAP versus VEH, respectively, w ere seen in inflammatory (-54.6% vs. -48.1%), noninflammatory (-45.1% vs. -39.4%), and total (-48.8% vs. -42.8%) lesions. In all subgroups, greater improvements with DAP versus VEH w ere noted in GAAS-RR and change in all lesion counts. Greater improvements in all outcome measures were seen in adults versus adolescents and in females versus males; results for C aucasians and non-Caucasians were similar. For GAAS-RR, DAP treatment (P<0.001), age (P<0.001), and gender (P=0.029) were significant predictors of improvement, based on logistic regression. For inflammatory and noninflammatory lesions, respectively, DAP treatment (P<0.001 for both), age (P<0.001 for both), and gender (P<0.001 and P≤0.025) were significant predictors of improvement, based on analysis of covariance. Incidence of adverse events was similar between subgroups of age, gender, and race and between treatment groups. Conclusion: Once-daily DAP improved acne severity versus VEH for all subgroups. Improvements were greater in adults versus adolescents and in females versus males. Results were similar for Caucasians and non- Caucasians. Activity of Dapsone versus Community and Hospital Bacterial Pathogens from the CANWARD Study Presenters: 1 George G. Zhanel, MD; 2 James Q. Del Rosso, DO Affiliations: 1 Department of Medical Microbiology and Infectious Diseases College of Medicine, Faculty of Health Sciences, University of Manitoba and Canadian Antimicrobial Resistance Alliance, Winnipeg, Canada; 2 Touro University College of Oseopathic Medicine, Henderson, NV, and Las Vegas Skin and Cancer Clinics/West Dermatology Group, Las Vegas, NV Background: Topical dapsone gel is a sulfone antibiotic approved for acne treatment. No microbiology studies were conducted during dapsone gel clinical trials and it is unclear whether 1) dapsone has antimicrobial activity with clinical relevance in dermatology and 2) S 4

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