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The purpose of this study is to determine and compare the bioavailability of clindamycin and clindamycin sulfoxide from repeated applications of Clindamycin 1%-Benzoyl Peroxide 3% Gel, Duac Topical Gel, and Duac Once Daily Gel under maximal-use conditions in subjects with acne.
This is a single center, randomized, open-label, parallel group, bioavailability study that will be conducted in male and female subjects, 12 to 45 years of age, who have moderate to severe acne (based on an ISGA score of 3 or greater at Baseline). Three clindamycin-BPO combination products will be evaluated.
Approximately 72 subjects will be enrolled and randomized to 1 of the 3 study product groups in a 1:1:1 ratio (24 subjects per group).
The study will consist of a 5 day dosing period during which subjects will apply 4 grams of study product once daily, in the morning, to the face, upper chest, upper back, and shoulders. Plasma concentrations of clindamycin and its metabolite clindamycin sulfoxide will be determined from blood samples collected at Baseline/Day 1; on Day 2, Day 3, and Day 4 before study product applications; on Day 5 before the study product application and at 1, 2, 4, 6, 8, and 12 hours after application; and on Day 6 at 24 hours after the last study product application.
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Clindamycin BPO (Duac)
J&S Studies, Inc.
Stiefel, a GSK Company
Published on BioPortfolio: 2014-08-27T03:13:21-0400
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