Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: results of a multicenter, randomized double-blind, controlled study.
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.


CONCLUSIONS
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.
Thiboutot
Diane M
DM
The Pennsylvania State University College of Medicine, Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA. dthiboutot@psu.edu
Weiss
Jonathan
J
Bucko
Alicia
A
Eichenfield
Lawrence
L
Jones
Terry
T
Clark
Scott
S
Liu
Yin
Y
Graeber
Michael
M
Kang
Sewon
S
D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene; D000293:Adolescent; D000328:Adult; D001585:Benzoyl Peroxide / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D003879:Dermatologic Agents; D004338:Drug Combinations; D009281:Naphthalenes; D000068816:Adapalene; D001585:Benzoyl Peroxide