title: Preadolescent moderate acne vulgaris: a randomized trial of the efficacy and safety of topical adapalene-benzoyl peroxides.
abstract: OBJECTIVE
  Evaluate the efficacy and safety of adapalene 0.1%-benzoyl peroxide 2.5% gel (adapalene-BPO) in patients 9-11 years old with acne vulgaris.<BR>
  
  
  METHODS
  Enrolled subjects were male or female, with a score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale. Subjects were randomized to receive adapalene-BPO or vehicle once daily for up to 12 weeks. Efficacy was evaluated by success rate (percentage of subjects rated "clear" or "almost clear") at each visit, median percentage changes from baseline in total, inflammatory and non-inflammatory lesion counts at each visit, the Children's Dermatology Life Quality Index (C DLQI) at baseline and week 12, and the Parent Assessment of Acne at week 12. Safety was assessed through evaluations of adverse events (AEs) and local tolerability [erythema, scaling, dryness, and stinging/burning on scales ranging from 0 (none) to 3 (severe)].<BR>
  
  
  RESULTS
  A total of 142 subjects were randomized to adapalene-BPO and 143 to vehicle. At study endpoint (week 12), adapalene-BPO was significantly superior to vehicle regarding treatment success (49.3% vs 15.9%, respectively), and regarding percentage reduction in total lesion counts (68.6% vs 19.3%), inflammatory (63.2% vs 14.3%), and non-inflammatory lesion counts (70.7% vs 14.6%) (all P<.001). More subjects using adapalene-BPO reported that their acne had no effect on their quality of life, and parents noted that their child's acne significantly improved. Adapalene-BPO was well tolerated, with mean tolerability scores less than 1 (mild).<BR>
  
  
  CONCLUSIONS
  In preadolescents with acne, adapalene-BPO leads to significantly superior treatment success and lesion count reduction compared to vehicle.
authors.affiliation: Rady Children's Hospital, San Diego and University of California, San Diego, CA, USA. leichenfield@rchsd.org
authors.forename: Lawrence F
authors.initials: LF
authors.lastname: Eichenfield
authors.forename: Zoe
authors.initials: Z
authors.lastname: Draelos
authors.forename: Anne W
authors.initials: AW
authors.lastname: Lucky
authors.forename: Adelaide A
authors.initials: AA
authors.lastname: Hebert
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Sugarman
authors.forename: Linda
authors.initials: L
authors.lastname: Stein Gold
authors.forename: Diane
authors.initials: D
authors.lastname: Rudisill
authors.forename: Hong
authors.initials: H
authors.lastname: Liu
authors.forename: Vasant
authors.initials: V
authors.lastname: Manna
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000503:physiopathology; D000068816:Adapalene; D000279:Administration, Cutaneous; D001585:Benzoyl Peroxide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D007249:Inflammation / Q000188:drug therapy / Q000473:pathology; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D009281:Naphthalenes; D000068816:Adapalene; D001585:Benzoyl Peroxide