title: Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial.
abstract: 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.
authors.affiliation: Department of Dermatology, Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
authors.forename: Diane
authors.initials: D
authors.lastname: Thiboutot
authors.forename: David M
authors.initials: DM
authors.lastname: Pariser
authors.forename: Nancy
authors.initials: N
authors.lastname: Egan
authors.forename: Javier
authors.initials: J
authors.lastname: Flores
authors.forename: James H
authors.initials: JH
authors.lastname: Herndon
authors.forename: Norman B
authors.initials: NB
authors.lastname: Kanof
authors.forename: Steven E
authors.initials: SE
authors.lastname: Kempers
authors.forename: Stuart
authors.initials: S
authors.lastname: Maddin
authors.forename: Yves P
authors.initials: YP
authors.lastname: Poulin
authors.forename: David C
authors.initials: DC
authors.lastname: Wilson
authors.forename: Joyce
authors.initials: J
authors.lastname: Hwa
authors.forename: Yin
authors.initials: Y
authors.lastname: Liu
authors.forename: Michael
authors.initials: M
authors.lastname: Graeber
mesh_terms: 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
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D009281:Naphthalenes; D000068816:Adapalene