Last updated: 11/07/2018 08:09:38
A clinical study to evaluate the safety and effectiveness of an investigational product called CT Gel
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of CT Gel in Subjects With Acne Vulgaris
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Absolute change from Baseline in lesion counts (total, inflammatory, and non-inflammatory) at Week 12 (end of study)
Timeframe: Baseline, Week 12
The percentage of participants who had a minimum 2-grade improvement in the Investigator’s Static Global Assessment (ISGA) score from Baseline to Week 12
Timeframe: Baseline, Week 12
Secondary outcomes:
Percent change from Baseline in lesion counts (inflammatory, non-inflammatory, and total) at Week 12
Timeframe: Baseline, Week 12
The percentage of participants with a Subjects Global Assessment Score of 0 or 1 at Week 12
Timeframe: Week 12
The percentage of participants who had ISGA scores of 0 or 1 at Week 12
Timeframe: Week 12
Interventions:
Drug: CT Gel
Drug: Clindamycin Gel (clindamycin )
Drug: Tretinoin Gel (tretinoin)
Drug: Vehicle Gel
Enrollment:
1649
Observational study model:
Not applicable
Primary completion date:
2009-07-04
Time perspective:
Not applicable
Clinical publications:
Jarratt MT, Brundage T. Efficacy and Safety of Clindamycin-Tretinoin Gel Versus Clindamycin or Tretinoin Alone in Acne Vulgaris: A Randomized, Double-Blind, Vehicle-Controlled Study. J Drugs Dermatol. 2012;11(3):318-326.
Medical condition
Acne Vulgaris
Product
benzoyl peroxide, clindamycin phosphate, clindamycin phosphate/tretinoin, tretinoin
Collaborators
GSK
Study date(s)
April 2008 to April 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- 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
- Any nodulo-cystic lesions at Baseline
- Pregnancy or breast feeding
Inclusion and exclusion criteria
Inclusion criteria:
- 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 criteria:
- 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.
Trial location(s)
Location
Dermatology Research Center, Inc.
Salt Lake City, UT, United States, 84124
Status
Study Complete
Location
Minnesota Clinical Study Center
Fridley, MN, United States, 55432
Status
Study Complete
Location
Burke Pharmaceutical Research
Hot Springs, AR, United States, 71913
Status
Study Complete
Location
Dermatology Research Associates, Inc.
Cincinnati, OH, United States, 45230
Status
Study Complete
Location
Massachusettes General Hospital - Clinical Unit for Research Trials in Skin
Boston, MA, United States, 02114
Status
Study Complete
Location
Coastal Clinical Research, Inc.
Mobile, AL, United States, 33608
Status
Study Complete
Location
Advanced Dermatolgy & Cosemtic Surgery
Ormond Beach, FL, United States, 32174
Status
Study Complete
Location
Academic Dermatology Research
Albuquerque, NM, United States, 87106
Status
Study Complete
Location
Tennessee Clinical Research
Nashville, TN, United States, 37215
Status
Study Complete
Location
Yardley Dermatology Associates
Yardley, PA, United States, 19067
Status
Study Complete
Location
Windsor Clinical Research Center, Inc.
Windsor, ON, Canada, N8W 5L7
Status
Study Complete
Location
Center for Dermatology, Cosmetic and Laser Surgery
Fremont, CA, United States, 94538
Status
Study Complete
Location
The Hair and Skin Research Treatment Center
Dallas, TX, United States, 75246
Status
Study Complete
Location
Longmont Medical Research Network
Longmont, CO, United States, 80501
Status
Study Complete
Location
Dermatology Associates of Knoxville, P.C.
Knoxville, TN, United States, 37934
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-07-04
Actual study completion date
2009-07-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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