A double-blinded, randomized, vehicle-controlled, multicenter, parallel-group study to assess the safety and efficacy of tretinoin gel microsphere 0.04% in the treatment of acne vulgaris in adults.
This double-blinded, randomized, vehicle-controlled, multicenter, parallel-group, 12-week, phase 4 study was conducted in adults with mild to moderate acne vulgaris. Of 178 subjects randomized to be treated, 88 subjects (49%) were treated with tretinoin gel microsphere 0.04% and 90 subjects (51%) were treated with vehicle. Inflammatory lesion counts were statistically significantly reduced at 2 weeks in tretinoin-treated subjects (P = .0110), and reductions in total lesion counts also were noted. The reduction in total lesion counts reached statistical significance at week 4 (P = .0305); at week 12, mean total, inflammatory, and noninflammatory lesion counts were statistically significantly lower in the tretinoin treatment group versus vehicle group (P < .05), and mean percentage reductions in lesion counts were significantly greater in the subjects with noninflammatory lesions treated with tretinoin compared with vehicle (P < .05). Mean percentage reductions in total, inflammatory, and noninflammatory lesion counts were 35.5%, 38.2%, and 33.6%, respectively, at week 12 for the tretinoin treatment group compared with 20.9%, 19.2%, and 20.4%, respectively, for the vehicle group (all P < .05). All adverse events were of mild or moderate intensity with the exception of severe skin irritation in one tretinoin-treated subject. At week 12, there were no statistically significant differences between treatment groups for any measured tolerability parameter.
Berger
Richard
R
Hill Top Research, Inc, East Brunswick, New Jersey, USA.
Barba
Alicia
A
Fleischer
Alan
A
Leyden
James J
JJ
Lucky
Anne
A
Pariser
David
D
Rafal
Elyse
E
Thiboutot
Diane
D
Wilson
David
D
Grossman
Rachel
R
Nighland
Marge
M
D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000279:Administration, Cutaneous; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D007641:Keratolytic Agents / Q000008:administration & dosage*; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage*
D005782:Gels; D007641:Keratolytic Agents; D014212:Tretinoin