Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

Completed · Phase 2

Conditions studied: Acne Vulgaris

In brief

Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris. You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Key facts

Study ID: NCT00713609
Run by: Stiefel, a GSK Company
People needed: 591
Starts: 2008-06-01
Expected to finish: 2009-03-01
Last updated by the study team: 2017-03-06

Who can join

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

You may qualify if…

Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.
Subjects must have acne on their face.
Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit.
Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements).
Subjects must be able to complete the study and to comply with study instructions.

You may not qualify if…

Subjects who are pregnant, trying to become pregnant, or breast-feeding.
Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination
History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products
Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months.
Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study.
Other exclusion criteria may apply.

Where it is running

Dermatology Research of Arkansas — Little Rock, Arkansas, United States
Center for Dermatology Cosmetic and Laser Surgery — Fremont, California, United States
Center for Dermatology and Laser Surgery — Sacramento, California, United States
Boulder Medical Center, P.C. — Boulder, Colorado, United States
Dermatology Associates Research — Coral Gables, Florida, United States
MedaPhase, Inc. — Newnan, Georgia, United States
Callender Center for Clinical Research — Mitchellville, Maryland, United States
Grekin Skin Institute — Warren, Michigan, United States
University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
Dermatology Consulting Services — High Point, North Carolina, United States
MS Hershey Medical Center — Hershey, Pennsylvania, United States
Rivergate Dermatology & Skin Care Center — Goodlettsville, Tennessee, United States
The Skin Wellness Center, PC — Knoxville, Tennessee, United States
Dermatology Treatment & Research Center — Dallas, Texas, United States
Suzanne Bruce and Associates, PA — Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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