Adapalene gel, 0.1%, as maintenance therapy for acne vulgaris: a randomized, controlled, investigator-blind follow-up of a recent combination study.
OBJECTIVE
To assess the maintenance effect of adapalene gel, 0.1%, relative to gel vehicle in subjects successfully treated in a previous 12-week study of adapalene-doxycycline, 100 mg, combination therapy.


METHODS
Multicenter, investigator-blind, randomized, controlled study.


METHODS
Thirty-four US centers.


METHODS
A total of 253 subjects with severe acne vulgaris who showed at least moderate improvement from baseline (50% improvement from baseline) when treated with either adapalene plus doxycycline or doxycycline plus gel vehicle in a previous 12-week study.


METHODS
Subjects were randomized to receive adapalene gel, 0.1%, or gel vehicle once daily for 16 weeks.


METHODS
Efficacy and safety criteria included maintenance rate (subjects maintaining at least 50% improvement in lesion counts from previous therapy), lesion counts (total, inflammatory, and noninflammatory), global severity assessment, cutaneous tolerability, and adverse events.


RESULTS
Adapalene maintenance therapy resulted in significantly larger maintenance rates (75% vs 54%; P<.001) and significantly lower lesion counts (total [P = .005], inflammatory [P = .01], and noninflammatory [P = .02]) compared with gel vehicle. Adapalene was safe and well tolerated in this study. Conclusion This study demonstrates a clinical benefit of continued treatment with adapalene gel, 0.1%, as a maintenance therapy for acne.
Thiboutot
Diane M
DM
The Pennsylvania State University College of Medicine, Milton S. Hershey Medical Center, Hershey, USA. dthiboutot@psu.edu
Shalita
Alan R
AR
Yamauchi
Paul S
PS
Dawson
Catherine
C
Kerrouche
Nabil
N
Arsonnaud
Stéphanie
S
Kang
Sewon
S
D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000068816:Adapalene; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D002648:Child; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome; D014481:United States
D003879:Dermatologic Agents; D005782:Gels; D009281:Naphthalenes; D000068816:Adapalene