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%) we...

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Bibliographic Details
Published inCutis (New York, N.Y.) Vol. 80; no. 2; p. 152
Main Authors Berger, Richard, Barba, Alicia, Fleischer, Alan, Leyden, James J, Lucky, Anne, Pariser, David, Rafal, Elyse, Thiboutot, Diane, Wilson, David, Grossman, Rachel, Nighland, Marge
Format Journal Article
LanguageEnglish
Published United States 01.08.2007
Subjects
Acne Vulgaris - drug therapy
Acne Vulgaris - pathology
Administration, Cutaneous
Adult
Double-Blind Method
Female
Gels
Humans
Keratolytic Agents - administration & dosage
Male
Microspheres
Middle Aged
Treatment Outcome
Tretinoin - administration & dosage
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Summary: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.
ISSN:0011-4162