Compared efficacy and safety of tretinoin 0.1% microsphere gel alone and in combination with benzoyl peroxide 6% cleanser for the treatment of acne vulgaris.

Author(s): Shalita AR, Rafal ES, Anderson DN, Yavel R, Landow S, Lee WL

Affiliation(s): Department of Dermatology, State University of New York, Health Science Center at Brooklyn, USA.

Publication date & source: 2003-08, Cutis., 72(2):167-72.

Publication type: Clinical Trial; Randomized Controlled Trial

Our purpose was to evaluate the efficacy and safety of a combination of benzoyl peroxide 6% cleanser and tretinoin 0.1% microsphere gel versus monotherapy with tretinoin 0.1% microsphere gel. Eighty-seven healthy males and nonpregnant nonlactating females between the ages of 12 and 30 years with moderate inflammatory acne vulgaris were enrolled in this randomized controlled, investigator-blind, parallel group clinical trial. Subjects were evaluated over 12 weeks for a total of 4 visits. The investigators and subjects completed questionnaires about the test medications. Data from the 56 subjects completing the protocol were considered in the analyses of efficacy and tolerability. The reduction in inflammatory lesions from baseline was significant for both treatment groups at the end of the study. However, there was a significantly greater reduction in the group receiving the combination regimen. Both treatment groups had significant reductions from baseline in noninflammatory lesions at week 12, but no differences were observed between treatment groups. With the exception of skin tightness, which was significantly greater at week 12 in the subjects who received the monotherapy, there were no significant differences between the 2 treatment groups with respect to localized irritation. Adverse events were rare in all subjects. Not only did the combination regimen result in a greater reduction of inflammatory acne lesions than use of the monotherapy but also it did not result in an increase in local irritation.