English

Abstract

A fixed dose combination gel with adapalene 0.1% and benzoyl peroxide 2.5% has been developed for the once daily treatment of acne vulgaris .This fixed combination was approved by U.S FDA in December 2008. This study was done in the Department of Dermatology, KIMS, Bangalore to assess the efficacy and adverse effects of topical adapalene 0.1%-benzoyl peroxide 2.5% combination gel as compared to topical adapalene 0.1% gel and 2.5% benzoyl peroxide gel (monotherapies) in the treatment of facial acne vulgaris. To the best of our knowledge, this is one of the few studies conducted in India. It was an open label study. Participants received either adapalene 0.1% gel, benzoyl peroxide 2.5% gel or adapalene 0.1% - benzoyl peroxide 2.5% combination gel for 12 weeks. Follow up was done at the end of 1,2,4,8 and 12 weeks. Evaluation included lesion count and adverse events. Participants included males and females aged between 18-38 years with grade 2 or 3 facial acne vulgaris as per investigators global assessment of acne scale. A total of 62 participants were recruited out of which 23 were males and 39 were females.88.71% participants completed the study. The study revealed that combination of adapalene 0.1% and benzoyl peroxide 2.5% gel was more effective in the treatment of facial acne as compared to adapalene 0.1% gel and benzoyl peroxide 2.5% gel (topical) monotherapies. The safety of combination of adapalene 0.1% and benzoyl peroxide 2.5% gel was comparable with adapalene 0.1% gel and benzoyl peroxide 2.5% gel monotherapies.