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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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Acne vulgaris (acne) is the most common skin disease in patients who have darker skin with most frequent sequelae of post inflammatory hyperpigmentation (PIH).
Topical treatment is the mainstay of acne therapy. The most commonly prescribed topical medications for acne include benzoyl peroxide, clindamycin, and retinoids. Despite their effectiveness in treati...
Topical tretinoin has been extensively studied in clinical trials, and its essential role in the treatment of acne vulgaris (acne) established through evidence-based guidelines.
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Acne vulgaris is a common skin disease characterized by increased sebum production, inflammation, and colonization of Propionibacterium acnes (P. acnes) on pilosebaceous follicles.
A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.
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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Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...
Acne is a common skin condition that causes spots to develop on the skin, usually on the face, back and chest.. The spots can range from blackheads and whiteheads which are often mild, to inflamed pus-filled pustules and cysts, which can be severe ...
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...