Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

Completed · Phase 3

Conditions studied: Acne Vulgaris

In brief

This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris

Key facts

Study ID

NCT00776919

Run by

Stiefel, a GSK Company

People needed

1315

Starts

2008-10-01

Expected to finish

2009-09-01

Last updated by the study team

2016-11-23

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be 12 to 45 years of age, inclusive, and in good general health.
• Clinical diagnosis of acne vulgaris
• Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
• Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
• Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.

You may not qualify if…

• Are pregnant or breast-feeding.
• Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes.
• Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks.
• Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
• Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks.
• Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
• Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks.
• Used abradents or facial procedures, within the past 2 weeks.
• Use medications that may exacerbate acne.
• Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product.
• Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.

Where it is running

• Rady Children's Hospital San Diego, Div. of Pediatric & Adolescents Dermatology — San Diego, California, United States
• The Laser Institute for Dermatology — Santa Monica, California, United States
• Cherry Creek Research, Inc. — Denver, Colorado, United States
• Skin Care Research, Inc. — Boca Raton, Florida, United States
• FXM Research — Miami, Florida, United States
• University of Miami Cosmetic Medicine and Research Institute — Miami Beach, Florida, United States
• Atlanta Dermatology & Vein Research Center, LLC — Alpharetta, Georgia, United States
• SKINQRI — Lincolnshire, Illinois, United States
• Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
• DermResearch, PLLC — Louisville, Kentucky, United States
• Somerset Skin Centre — Troy, Michigan, United States
• Dermatology Associates of Rochester, PC — Rochester, New York, United States
• DermResearch Center of New York — Stony Brook, New York, United States
• The Skin Wellness Center, PC — Knoxville, Tennessee, United States
• Arlington Center for Dermatology — Arlington, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Dermatology and Skin Care Center FXM Research International — Belize City, Belize
• Dr. Moguel's Clinic/FXM Research International — Belize City, Belize
• Guildford Dermatology Specialist — Surrey, British Columbia, Canada
• Dermatrial Research — Hamilton, Ontario, Canada
• Lynderm Research, Inc. — Markham, Ontario, Canada
• North Bay Dermatology Centre — North Bay, Ontario, Canada
• CRDQ Centre de Recherche Dermatologique du Quebec — Québec, Quebec, Canada
• Nexus Clinical Research — St. John's, Canada

Full record on ClinicalTrials.gov

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