A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel

Completed · Phase 3

Conditions studied: Acne Vulgaris, Acne

In brief

The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.

Key facts

Study ID

NCT00689117

Run by

Stiefel, a GSK Company

People needed

1649

Starts

2008-04-01

Expected to finish

2009-05-01

Last updated by the study team

2017-05-30

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female 12 years of age or older in good general health
• Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline

You may not qualify if…

• Any nodulo-cystic lesions at Baseline
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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