Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: Results of a multicenter, randomized double-blind, controlled study - 19/08/11
, Jonathan Weiss, MD b, Alicia Bucko, DO c, Lawrence Eichenfield, MD d, Terry Jones, MD e, Scott Clark, MD f, Yin Liu, PhD g, Michael Graeber, MD g, ⁎ , Sewon Kang, MD hAdapalene-BPO Study Group
Correspondence to: Diane M. Thiboutot, MD, Department of Dermatology, HU14, Milton S. Hershey Medical Center, The Pennsylvania State University, PO Box 850, Hershey, PA 17033-0850.Reprint requests: Michael Graeber, Galderma Research & Development, 5 Cedar Brook Dr, Suite 1, Cranbury, NJ 08512.Abstract |
Background |
A fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% has been developed for the once-daily treatment of acne.
Objective |
To evaluate the efficacy and safety of adapalene 0.1% -BPO 2.5% fixed combination gel (adapalene-BPO) for the treatment of acne.
Methods |
A total of 517 subjects were randomized in a double-blind controlled trial to receive either adapalene-BPO, adapalene, BPO, or vehicle for 12 weeks (2:2:2:1 randomization). Evaluation included success rate (subjects “clear” or “almost clear”), lesion count, cutaneous tolerability, and adverse events.
Results |
The fixed-dose combination gel of adapalene and BPO was significantly more effective than corresponding monotherapies, with significant differences in total lesion counts observed as early as 1 week. Adverse event frequency and cutaneous tolerability profile for adapalene-BPO were similar to adapalene monotherapy.
Limitations |
These data were generated in a controlled trial. Results obtained in clinical practice could differ.
Conclusions |
The fixed-dose combination of adapalene and BPO provides significantly greater efficacy for the treatment of acne vulgaris as early as week 1 relative to monotherapies, with a comparable safety profile to adapalene.
Le texte complet de cet article est disponible en PDF.Abbreviations used : BPO, IGA, ITT, LOCF, PP
Plan
| Funding source: Galderma R&D, Princeton, NJ. |
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| Disclosure: The investigating authors received payments for this research project. Drs Liu and Graeber are employees of Galderma R&D. Drs Thiboutot, Weiss, and Kang have served as a consultants and speakers for Galderma Laboratories. Drs Bucko, Jones, and Eichenfield have served as consultants for Galderma. |
Vol 57 - N° 5
P. 791-799 - novembre 2007 Retour au numéro
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