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Photographic review of results from a clinical study comparing benzoyl peroxide 5%/clindamycin 1% topical gel with vehicle in the treatment of rosacea.

Author(s): Leyden JJ, Thiboutot D, Shalita A

Affiliation(s): Skin Study Center, Broomall, Pennsylvania, USA.

Publication date & source: 2004-06, Cutis., 73(6 Suppl):11-7.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

A photographic analysis was conducted of results from a randomized, double-blind, vehicle-controlled, 12-week study that assessed the efficacy of topical benzoyl peroxide 5%/clindamycin 1% (BP/C) gel (BenzaClin) versus vehicle in the treatment of rosacea. The objective was to compare the baseline and end-of-treatment photographs of patients treated with BP/C versus those treated with vehicle. Patients were randomized to receive once-daily treatment with BP/C or vehicle for 12 weeks. Three blinded, independent reviewers evaluated papule and pustule severity at baseline and at week 12 for each patient. An Overall Global Improvement (OGI) scale was used to assess efficacy. Fifty patients (BP/C, 26; vehicle, 24) were evaluated. At end of treatment, significant (P < .001) improvements were seen in the number of papules and pustules based on the OGI scale for patients receiving BP/C. At week 12, 7. 7% of patients treated with BP/C were rated as "clear/nearly clear" from baseline compared with a change of 0% in patients receiving vehicle. An additional 15.4% of patients were rated as having a "marked improvement" from baseline compared with a change of 4.2% in patients receiving vehicle. Interrater reliability was high, based on intraclass correlation coefficient (ICC) of 0.647 (BP/C) and 0.722 (vehicle) on the OGI scale (P < .001). These results showed that BP/C was significantly more effective than vehicle in improving papules and pustules associated with rosacea.

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