TY - JOUR
T1 - 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
AU - Berger, Richard
AU - Barba, Alicia
AU - Fleischer, Alan
AU - Leyden, James J.
AU - Lucky, Anne
AU - Pariser, David
AU - Rafal, Elyse
AU - Thiboutot, Diane
AU - Wilson, David
AU - Grossman, Rachel
AU - Nighland, Marge
PY - 2007/8/1
Y1 - 2007/8/1
N2 - 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.
AB - 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.
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M3 - Article
C2 - 17944177
AN - SCOPUS:34548286042
SN - 0011-4162
VL - 80
SP - 152
EP - 157
JO - Cutis
JF - Cutis
IS - 2
ER -