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A Study to Evaluate the Absorption of Clindamycin Following the Use of Clindamycin 1%-Benzoyl Peroxide 3% Gel, Duac Topical Gel, and Duac Once Daily Gel in Subjects With Acne Vulgaris

2014-08-27 03:13:21 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Acne Vulgaris

Intervention

Clindamycin BPO (Duac)

Location

J&S Studies, Inc.
College Station
Texas
United States
77845

Status

Recruiting

Source

Stiefel, a GSK Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:21-0400

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Medical and Biotech [MESH] Definitions

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A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors.

Severe and chronic form of acne characterized by large, burrowing abscesses associated with disfigurement.

Visible efflorescent lesions of the skin caused by acne or resembling acne. (Dorland, 28th ed, p18, 575)

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