Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne
NCT ID: NCT00713609
Last Updated: 2017-03-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
591 participants
INTERVENTIONAL
2008-06-30
2009-03-31
Brief Summary
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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.
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Detailed Description
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Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Benzoyl peroxide/clindamycin gel + tazarotene cream
Benzoyl peroxide gel
5% benzoyl peroxide in a gel applied topically once a day
Clindamycin gel
1% clindamycin phosphate applied topically once a day
Tazarotene cream
0.1 % tazarotene in a cream applied topically once a day
2
Benzoyl peroxide/clindamycin gel + vehicle cream
Benzoyl peroxide gel
5% benzoyl peroxide in a gel applied topically once a day
Clindamycin gel
1% clindamycin phosphate applied topically once a day
Vehicle cream
Vehicle cream is an identical cream without the active ingredients
3
Benzoyl peroxide gel + tazarotene cream
Benzoyl peroxide gel
5% benzoyl peroxide in a gel applied topically once a day
Tazarotene cream
0.1 % tazarotene in a cream applied topically once a day
4
Clindamycin gel + tazarotene cream
Clindamycin gel
1% clindamycin phosphate applied topically once a day
Tazarotene cream
0.1 % tazarotene in a cream applied topically once a day
5
Vehicle gel+ tazarotene cream
Tazarotene cream
0.1 % tazarotene in a cream applied topically once a day
Vehicle gel
Vehicle gel is an identical gel without the active ingredients
6
Vehicle gel + vehicle cream
Vehicle gel
Vehicle gel is an identical gel without the active ingredients
Vehicle cream
Vehicle cream is an identical cream without the active ingredients
Interventions
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Benzoyl peroxide gel
5% benzoyl peroxide in a gel applied topically once a day
Clindamycin gel
1% clindamycin phosphate applied topically once a day
Tazarotene cream
0.1 % tazarotene in a cream applied topically once a day
Vehicle gel
Vehicle gel is an identical gel without the active ingredients
Vehicle cream
Vehicle cream is an identical cream without the active ingredients
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
45 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Stiefel, a GSK Company
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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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
Countries
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Other Identifiers
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114570
Identifier Type: -
Identifier Source: org_study_id
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