A two-center, double-blinded, randomized trial testing the tolerability and efficacy of a novel therapeutic agent for cellulite reduction.

INTRODUCTION Cellulite is the unsightly dimpling and nodularity found on the thighs and buttocks of many postadolescent women. Unfortunately, poor understanding of its pathophysiology coupled with very few scientifically based studies have left us with limited treatment options that are tolerable and effective. PURPOSE To review current concepts of the etiology and nature of cellulite and summarize available treatment options. To evaluate a novel, pathophysiologically based, topical agent for treatment. MATERIALS AND METHODS A total of 40 women with a moderate degree of cellulite (20 from each of the two research centers) entered a double-blinded, randomized trial where an anticellulite cream was applied on a nightly basis to the affected sites for four continuous weeks. Each subject was randomized to receive active cream on either the right or left leg, with the contralateral side serving as placebo control. Bioceramic-coated neoprene shorts were worn overnight to enhance penetration of the topical agents by occlusion. High-quality digital photography was taken before treatment and after 4 weeks, with tangential full-spectrum lighting. Five blinded, independent physician reviewers assessed the photographs for improvement. Subject questionnaires were completed to assess tolerability and efficacy. RESULTS Of the 34 subjects who completed the study, 62% (21/34) noticed an overall improvement in their cellulite, with 62% (13/21) reporting greater improvement in the thigh that received active product. All 34 subjects found the shorts and creams easy and pleasant to use. Overall, the average measured decrease in thigh circumference was 1.9 cm (range: 0.1-4.5) with active product, and 1.3 cm (range: 0.1-3.0) with placebo. Upon review of the pre- and poststudy photographs, dermatologist evaluators found thighs treated with active product showed greater improvement than thighs treated with placebo in 68% of subjects. CONCLUSIONS The active topical agent used in this study was found to be effective in reducing the appearance of cellulite. All subjects tolerated the formulation well with no adverse effects. The success of this research validates the pathophysiologic concepts used to formulate the topical compound. This study both increases our understanding of the nature of cellulite and establishes a tolerable, effective product to treat it.