Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial.
BACKGROUND
A new 0.3% gel formulation of adapalene has been developed.


OBJECTIVE
We sought to provide evidence of the superiority of adapalene gel 0.3% over adapalene gel 0.1% and gel vehicle in the treatment of acne.


METHODS
A total of 653 patients were randomized to receive adapalene gel 0.3%, adapalene gel 0.1%, or vehicle once daily for 12 weeks (2:2:1 randomization). Analysis for efficacy was conducted on correlated repeated measurements at weeks 8 and 12 using Generalized Estimating Equation methodology.


RESULTS
Adapalene gel 0.3% was significantly superior to adapalene gel 0.1% and vehicle in success rate, total lesion count, and inflammatory lesion count. A consistent, dose-dependent effect was demonstrated for all efficacy measures. Signs and symptoms were mostly mild to moderate and transient in nature.


CONCLUSIONS
Adjunctive topical or oral agents and their impact on acne were not studied in this trial.


CONCLUSIONS
Adapalene gel 0.3% was effective and well tolerated in the treatment of acne.
Thiboutot
Diane
D
Department of Dermatology, Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
Pariser
David M
DM
Egan
Nancy
N
Flores
Javier
J
Herndon
James H
JH
Kanof
Norman B
NB
Kempers
Steven E
SE
Maddin
Stuart
S
Poulin
Yves P
YP
Wilson
David C
DC
Hwa
Joyce
J
Liu
Yin
Y
Graeber
Michael
M
D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D002648:Child; D004305:Dose-Response Relationship, Drug; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D009281:Naphthalenes; D000068816:Adapalene