The efficacy and safety of adapalene gel 0.3% in the treatment of acne vulgaris: A randomized, multicenter, investigator-blinded, controlled comparison study versus adapalene gel 0.1% and vehicle.
A randomized, multicenter, investigator-blinded, active- and vehicle-controlled study was conducted to evaluate the efficacy and safety of adapalene gel 0.3% versus adapalene gel 0.1% and the corresponding gel vehicle. Subjects were assigned randomly to receive either adapalene gel 0.3%, adapalene gel 0.1%, or vehicle once daily for 12 weeks. A total of 214 subjects with moderate to moderately severe acne vulgaris were enrolled, and 85% of subjects completed the study. Adapalene gel 0.3% was significantly superior to adapalene gel 0.1% in total and noninflammatory lesion counts and in global severity score (P < .05 for all). A concentration-dependent increase in clinical benefit for all efficacy assessments was observed. As expected, there were also statistically significant differences in all efficacy parameters in the adapalene gel 0.3% group relative to the vehicle group (P < .001 for all). Treatment-related adverse events were mostly mild-to-moderate and similar between active groups. The results of this study show that adapalene gel 0.3% was superior to adapalene gel 0.1% and vehicle in the treatment of moderate to moderately severe acne while retaining a similar safety and tolerability profile to adapalene 0.1% gel.
Pariser
David M
DM
Virginia Clinical Research, Inc, Norfolk, USA.
Thiboutot
Diane M
DM
Clark
Scott D
SD
Jones
Terry M
TM
Liu
Yin
Y
Graeber
Michael
M
D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D002648:Child; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D014677:Pharmaceutical Vehicles; D016037:Single-Blind Method
D003879:Dermatologic Agents; D005782:Gels; D009281:Naphthalenes; D014677:Pharmaceutical Vehicles; D000068816:Adapalene