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A Randomized, Controlled, Investigator-Blind Follow-up of a Recent Combination Study

Diane M. Thiboutot, MD; Alan R. Shalita, MD; Paul S. Yamauchi, MD, PhD; Catherine Dawson; Nabil Kerrouche; Stéphanie Arsonnaud; Sewon Kang, MD

Arch Dermatol. 2006;142:597-602.

Objective  To assess the maintenance effect of adapalene gel, 0.1%, relative to gel vehicle in subjects successfully treated in a previous 12-week study of adapalene-doxycycline, 100 mg, combination therapy.

Design  Multicenter, investigator-blind, randomized, controlled study.

Setting  Thirty-four US centers.

Subjects  A total of 253 subjects with severe acne vulgaris who showed at least moderate improvement from baseline (50% improvement from baseline) when treated with either adapalene plus doxycycline or doxycycline plus gel vehicle in a previous 12-week study.

Interventions  Subjects were randomized to receive adapalene gel, 0.1%, or gel vehicle once daily for 16 weeks.

Main Outcome Measures  Efficacy and safety criteria included maintenance rate (subjects maintaining at least 50% improvement in lesion counts from previous therapy), lesion counts (total, inflammatory, and noninflammatory), global severity assessment, cutaneous tolerability, and adverse events.

Results  Adapalene maintenance therapy resulted in significantly larger maintenance rates (75% vs 54%; P<.001) and significantly lower lesion counts (total [P = .005], inflammatory [P = .01], and noninflammatory [P = .02]) compared with gel vehicle. Adapalene was safe and well tolerated in this study.

Conclusion  This study demonstrates a clinical benefit of continued treatment with adapalene gel, 0.1%, as a maintenance therapy for acne.

Author Affiliations: The Pennsylvania State University College of Medicine, Milton S. Hershey Medical Center, Hershey (Dr Thiboutot); SUNY Downstate Medical Center, Brooklyn, NY (Dr Shalita); University of California, Los Angeles, School of Medicine, Santa Monica (Dr Yamauchi); Galderma Research & Development, Princeton, NJ (Mss Dawson and Arsonnaud); Galderma Medical Affairs, Sophia-Antipolis, France (Mr Kerrouche); and University of Michigan, Ann Arbor (Dr Kang).

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