A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
NCT ID: NCT00689117
Last Updated: 2017-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1649 participants
INTERVENTIONAL
2008-04-30
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
CT Gel
CT Gel
Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
2
Clindamycin Gel (clindamycin)
Clindamycin Gel (clindamycin )
Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
3
Tretinoin Gel (tretinoin)
Tretinoin Gel (tretinoin)
Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
4
Vehicle Gel
Vehicle Gel
Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks
Interventions
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CT Gel
Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
Clindamycin Gel (clindamycin )
Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
Tretinoin Gel (tretinoin)
Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
Vehicle Gel
Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline
Exclusion Criteria
* Pregnancy or breast feeding
* History or presence of regional enteritis or inflammatory bowel disease or similar symptoms.
* Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start.
* Use of topical anti-acne medications within the past 2 weeks.
* Use of topical or systemic antibiotics on the face within the past 2 weeks.
* Use of topical or systemic corticosteroids within the past 2 weeks.
* Use of systemic retinoids within the past 3 months.
* Use of astringents, toners and skin cleansers for less than 2 weeks prior to the start of the study.
* Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
* Concomitant use of mega-doses of certain vitamins, such as vitamin D (\>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
* Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
* Concomitant use of tanning booths or sunbathing.
* Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, retinoids or excipients of the study product
* A significant medical history of or are currently immunocompromised
* Current drug or alcohol abuse. (Drug screening not required.)
* Use of any investigational therapy within 4 weeks of enrollment.
* Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
12 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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Radiant Research
Birmingham, Alabama, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Center for Dermatology, Cosmetic and Laser Surgery
Fremont, California, United States
University Clinical Trials
San Diego, California, United States
Longmont Medical Research Network
Longmont, Colorado, United States
FXM Research Corporation
Miami, Florida, United States
FXM Research - Miramar
Miramar, Florida, United States
Advanced Dermatolgy & Cosemtic Surgery
Ormond Beach, Florida, United States
Dermatology Specialists
Louisville, Kentucky, United States
Massachusettes General Hospital - Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Medical Center
Detroit, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Skin Specialists, P.C.
Omaha, Nebraska, United States
Academic Dermatology Research
Albuquerque, New Mexico, United States
Dermatology Research Associates, Inc.
Cincinnati, Ohio, United States
Yardley Dermatology Associates
Yardley, Pennsylvania, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Dermatology Associates of Knoxville, P.C.
Knoxville, Tennessee, United States
Tennessee Clinical Research
Nashville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, United States
J & S Studies, Inc.
College Station, Texas, United States
The Hair and Skin Research Treatment Center
Dallas, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
Premier Clincial Research
Spokane, Washington, United States
Advanced Healthcare
Milwaukee, Wisconsin, United States
Dermatology And Skin Centre
Belize City, , Belize
Dr. Moguel's Clinic
Belize City, , Belize
K. Papp Clinical Research, Inc.
Waterloo, Ontario, Canada
Windsor Clinical Research Center, Inc.
Windsor, Ontario, Canada
Innovaderm Research, Inc.
Montreal, Quebec, Canada
Countries
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Other Identifiers
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W0265-03
Identifier Type: OTHER
Identifier Source: secondary_id
114681
Identifier Type: -
Identifier Source: org_study_id
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