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 adapalenedoxycycline, 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.
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