Preadolescent Moderate Acne Vulgaris: A Randomized Trial of the Efficacy and Safety of Topical Adapalene-Benzoyl Peroxides
June 2013 | Volume 12 | Issue 6 | Original Article | 611 | Copyright © June 2013
Lawrence F. Eichenfield MD,a Zoe Draelos MD,b Anne W. Lucky MD,c Adelaide A. Hebert MD,d Jeffrey Sugarman MD,e Linda Stein Gold MD,f Diane Rudisill BS,g Hong Liu MS,g and Vasant Manna MDg
aRady Children's Hospital, San Diego, and University of California, San Diego, CA
bPrivate Practice, High Point, and Duke University School of Medicine, Durham, NC
cDepartment of Pediatrics, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
dDepartments of Dermatology and Pediatrics, University of Texas-Houston Medical School, Houston, TX
eUniversity of California, San Francisco, CA; fDepartment of Dermatology, Henry Ford Health Systems, Detroit, MI
gGalderma R&D, Cranbury, NJ
METHODS: Enrolled subjects were male or female, with a score of 3 (moderate) on the Investigator’s Global Assessment (IGA) scale. Subjects were randomized to receive adapalene-BPO or vehicle once daily for up to 12 weeks. Efficacy was evaluated by success rate (percentage of subjects rated "clear" or "almost clear") at each visit, median percentage changes from baseline in total, inflammatory and non-inflammatory lesion counts at each visit, the Children’s Dermatology Life Quality Index (C DLQI) at baseline and week 12, and the Parent Assessment of Acne at week 12. Safety was assessed through evaluations of adverse events (AEs) and local tolerability [erythema, scaling, dryness, and stinging/burning on scales ranging from 0 (none) to 3 (severe)].
RESULTS: A total of 142 subjects were randomized to adapalene-BPO and 143 to vehicle. At study endpoint (week 12), adapalene-BPO was significantly superior to vehicle regarding treatment success (49.3% vs 15.9%, respectively), and regarding percentage reduction in total lesion counts (68.6% vs 19.3%), inflammatory (63.2% vs 14.3%), and non-inflammatory lesion counts (70.7% vs 14.6%) (all P<.001). More subjects using adapalene-BPO reported that their acne had no effect on their quality of life, and parents noted that their child’s acne significantly improved. Adapalene-BPO was well tolerated, with mean tolerability scores less than 1 (mild).
CONCLUSIONS: In preadolescents with acne, adapalene-BPO leads to significantly superior treatment success and lesion count reduction compared to vehicle.
J Drugs Dermatol. 2013;12(6):611-618.