Funding sources This study was supported by Galderma R&D, Sophia-Antipolis, France.
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
Article first published online: 20 MAY 2011
© 2011 The Authors. BJD © 2011 British Association of Dermatologists
British Journal of Dermatology
Volume 164, Issue 6, pages 1376–1382, June 2011
How to Cite
Poulin, Y., Sanchez, N.P., Bucko, A., Fowler, J., Jarratt, M., Kempers, S., Kerrouche, N., Dhuin, J.-C. and Kunynetz, R. (2011), 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. British Journal of Dermatology, 164: 1376–1382. doi: 10.1111/j.1365-2133.2011.10344.x
Conflicts of interest The investigating authors received payments for conducting the study. J.F. and R.K. have served as consultants and speakers for Galderma. M.J. has received honoraria from Galderma. N.K. and J.-C.D. are employees of Galderma R&D.
ClinicalTrials.gov registration number: NCT00687908.
- Issue published online: 25 MAY 2011
- Article first published online: 20 MAY 2011
- Accepted manuscript online: 1 APR 2011 10:27AM EST
- Accepted for publication 16 December 2010
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.