title: Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: results of a multicenter, randomized double-blind, controlled study.
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.
  
  
  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.
authors.affiliation: The Pennsylvania State University College of Medicine, Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA. dthiboutot@psu.edu
authors.forename: Diane M
authors.initials: DM
authors.lastname: Thiboutot
authors.forename: Jonathan
authors.initials: J
authors.lastname: Weiss
authors.forename: Alicia
authors.initials: A
authors.lastname: Bucko
authors.forename: Lawrence
authors.initials: L
authors.lastname: Eichenfield
authors.forename: Terry
authors.initials: T
authors.lastname: Jones
authors.forename: Scott
authors.initials: S
authors.lastname: Clark
authors.forename: Yin
authors.initials: Y
authors.lastname: Liu
authors.forename: Michael
authors.initials: M
authors.lastname: Graeber
authors.forename: Sewon
authors.initials: S
authors.lastname: Kang
mesh_terms: 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
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D009281:Naphthalenes; D000068816:Adapalene; D001585:Benzoyl Peroxide