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