Status:
COMPLETED
A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Acne Vulgaris
Acne
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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 Vehic...
Detailed Description
CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expec...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
1649 Patients enrolled
Trial Details
Trial ID
NCT00689117
Start Date
April 1 2008
End Date
May 1 2009
Last Update
May 30 2017
Active Locations (32)
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1
Radiant Research
Birmingham, Alabama, United States, 35209
2
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 33608
3
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
4
Center for Dermatology, Cosmetic and Laser Surgery
Fremont, California, United States, 94538