Clinical trial NCT00689117: A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Acne
Keywords: Acne Vulgaris
Acne
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-06-03
Enrollment: 1649
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Vehicle Gel for the treatment of acne vulgaris.

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 expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

Eligibility 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.

Primary outcomes:
measure: Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
timeFrame: Baseline, Week 12
measure: 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:
measure: Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
timeFrame: Baseline, Week 12
measure: The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12
timeFrame: Week 12
measure: The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Fremont
country: United States
facility: Center for Dermatology, Cosmetic and Laser Surgery
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Miami
country: United States
facility: FXM Research Corporation
state: Florida
city: Miramar
country: United States
facility: FXM Research - Miramar
state: Florida
city: Ormond Beach
country: United States
facility: Advanced Dermatolgy & Cosemtic Surgery
state: Florida
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Boston
country: United States
facility: Massachusettes General Hospital - Clinical Unit for Research Trials in Skin
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, P.C.
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology Research
state: New Mexico
city: Cincinnati
country: United States
facility: Dermatology Research Associates, Inc.
state: Ohio
city: Yardley
country: United States
facility: Yardley Dermatology Associates
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: The Hair and Skin Research Treatment Center
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Spokane
country: United States
facility: Premier Clincial Research
state: Washington
city: Milwaukee
country: United States
facility: Advanced Healthcare
state: Wisconsin
city: Belize City
country: Belize
facility: Dermatology And Skin Centre
city: Belize City
country: Belize
facility: Dr. Moguel's Clinic
city: Waterloo
country: Canada
facility: K. Papp Clinical Research, Inc.
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research Center, Inc.
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research, Inc.
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: