PMID- 23839175
OWN - NLM
STAT- MEDLINE
DCOM- 20140210
LR  - 20151119
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 12
IP  - 6
DP  - 2013 Jun 1
TI  - Preadolescent moderate acne vulgaris: a randomized trial of the efficacy and 
      safety of topical adapalene-benzoyl peroxides.
PG  - 611-8
AB  - 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.
FAU - Eichenfield, Lawrence F
AU  - Eichenfield LF
AD  - Rady Children's Hospital, San Diego and University of California, San Diego, CA, 
      USA. leichenfield@rchsd.org
FAU - Draelos, Zoe
AU  - Draelos Z
FAU - Lucky, Anne W
AU  - Lucky AW
FAU - Hebert, Adelaide A
AU  - Hebert AA
FAU - Sugarman, Jeffrey
AU  - Sugarman J
FAU - Stein Gold, Linda
AU  - Stein Gold L
FAU - Rudisill, Diane
AU  - Rudisill D
FAU - Liu, Hong
AU  - Liu H
FAU - Manna, Vasant
AU  - Manna V
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Dermatologic Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Gels)
RN  - 0 (Naphthalenes)
RN  - 1L4806J2QF (Adapalene)
RN  - W9WZN9A0GM (Benzoyl Peroxide)
SB  - IM
MH  - Acne Vulgaris/*drug therapy/physiopathology
MH  - Adapalene
MH  - Administration, Cutaneous
MH  - Benzoyl Peroxide/administration & dosage/adverse effects/*therapeutic use
MH  - Child
MH  - Dermatologic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Gels
MH  - Humans
MH  - Inflammation/drug therapy/pathology
MH  - Male
MH  - Naphthalenes/administration & dosage/adverse effects/*therapeutic use
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2013/07/11 06:00
MHDA- 2014/02/11 06:00
CRDT- 2013/07/11 06:00
PHST- 2013/07/11 06:00 [entrez]
PHST- 2013/07/11 06:00 [pubmed]
PHST- 2014/02/11 06:00 [medline]
AID - S1545961613P0611X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2013 Jun 1;12(6):611-8.