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

• Published in: Cutis (New York, N.Y.) Vol. 80; no. 2; pp. 152 - 157
• Main Authors: BERGER, Richard, BARBA, Alicia, NIGHLAND, Marge, FLEISCHER, Alan, LEYDEN, James J, LUCKY, Anne, PARISER, David, RAFAL, Elyse, THIBOUTOT, Diane, WILSON, David, GROSSMAN, Rachel
• Format: Journal Article
• Language: English
• Published: Chatham, NJ Quadrant HealthCom 01-08-2007
• Subjects: Acne Vulgaris - drug therapy; Acne Vulgaris - pathology; Administration, Cutaneous; Adult; Biological and medical sciences; Dermatology; Double-Blind Method; Female; Gels; Humans; Keratolytic Agents - administration & dosage; Male; Medical sciences; Microspheres; Middle Aged; Skin involvement in other diseases. Miscellaneous. General aspects; Treatment Outcome; Tretinoin - administration & dosage; Human; Antineoplastic agent; Skin disease; Microsphere; Dermatology; Toxicity; Multicenter study; Retinoid; Acne vulgaris; Treatment; Double blind study; Adult; Safety; Tretinoin
• ISSN: 0011-4162; 2326-6929

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.