A 6-month maintenance therapy with adapalene-benzoyl peroxide gel prevents relapse and continuously improves efficacy among patients with severe acne vulgaris: results of a randomized controlled trial.

Author(s): Poulin Y, Sanchez NP, Bucko A, Fowler J, Jarratt M, Kempers S, Kerrouche N, Dhuin JC, Kunynetz R

Affiliation(s): Centre de Recherche Dermatologique du Quebec Metropolitan, Quebec City, QC, Canada. poulinyves@videotron.ca

Publication date & source: 2011-06, Br J Dermatol., 164(6):1376-82. Epub 2011 May 20.

Publication type: Research Support, Non-U.S. Gov't

BACKGROUND: Acne vulgaris is a chronic and frequently recurring disease. A fixed-dose adapalene-benzoyl peroxide (adapalene-BPO) gel is an efficacious and safe acne treatment. OBJECTIVES: To assess the long-term effect of adapalene-BPO on relapse prevention among patients with severe acne after successful initial treatments. METHODS: This is a multicentre, double-blind, randomized and controlled study. In total, 243 subjects who had severe acne vulgaris and at least 50% global improvement after a previous 12-week treatment were randomized into the present study to receive adapalene-BPO gel or its vehicle once daily for 24 weeks. RESULTS: At week 24, compared with vehicle, adapalene-BPO resulted in significantly higher lesion maintenance success rate (defined as having at least 50% improvement in lesion counts achieved in initial treatment) for all types of lesions (total lesions: 78.9% vs. 45.8%; inflammatory lesions: 78.0% vs. 48.3%; noninflammatory lesions: 78.0% vs. 43.3%; all P < 0.001). Significantly more subjects with adapalene-BPO than with vehicle had the same or better Investigator's Global Assessment score at week 24 than at baseline (70.7% vs. 34.2%; P < 0.001). The time when 25% of subjects relapsed was 175 days with adapalene-BPO and 56 days with vehicle (17 weeks earlier; P < 0.0001). Adapalene-BPO led to further decrease of lesion counts during the study and 45.7% of subjects were 'clear' or 'almost clear' at week 24. It was also safe and well tolerated in the study. CONCLUSIONS: Adapalene-BPO not only prevents the occurrence of relapse among patients with severe acne, but also continues to reduce disease symptoms during 6 months. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists.