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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00689117
First received: May 24, 2008
Last updated: September 22, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Acne
Drug: CT Gel
Drug: Clindamycin Gel (clindamycin )
Drug: Tretinoin Gel (tretinoin)
Drug: Vehicle Gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.

  • 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 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.


Secondary Outcome Measures:
  • Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.

  • The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts.

  • The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion.


Enrollment: 1649
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CT Gel
Drug: CT Gel
Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
Active Comparator: 2
Clindamycin Gel (clindamycin)
Drug: Clindamycin Gel (clindamycin )
Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
Active Comparator: 3
Tretinoin Gel (tretinoin)
Drug: Tretinoin Gel (tretinoin)
Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
Placebo Comparator: 4
Vehicle Gel
Drug: Vehicle Gel
Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689117

  Hide Study Locations
Locations
United States, Alabama
Radiant Research
Birmingham, Alabama, United States, 35209
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 33608
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Center for Dermatology, Cosmetic and Laser Surgery
Fremont, California, United States, 94538
University Clinical Trials
San Diego, California, United States, 92103
United States, Colorado
Longmont Medical Research Network
Longmont, Colorado, United States, 80501
United States, Florida
FXM Research Corporation
Miami, Florida, United States, 33175
FXM Research - Miramar
Miramar, Florida, United States, 33027
Advanced Dermatolgy & Cosemtic Surgery
Ormond Beach, Florida, United States, 32174
United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusettes General Hospital - Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Nebraska
Skin Specialists, P.C.
Omaha, Nebraska, United States, 68144
United States, New Mexico
Academic Dermatology Research
Albuquerque, New Mexico, United States, 87106
United States, Ohio
Dermatology Research Associates, Inc.
Cincinnati, Ohio, United States, 45230
United States, Pennsylvania
Yardley Dermatology Associates
Yardley, Pennsylvania, United States, 19067
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, Tennessee
Dermatology Associates of Knoxville, P.C.
Knoxville, Tennessee, United States, 37934
Tennessee Clinical Research
Nashville, Tennessee, United States, 37215
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J & S Studies, Inc.
College Station, Texas, United States, 77840
The Hair and Skin Research Treatment Center
Dallas, Texas, United States, 75246
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84124
United States, Washington
Premier Clincial Research
Spokane, Washington, United States, 99204
United States, Wisconsin
Advanced Healthcare
Milwaukee, Wisconsin, United States, 53209
Belize
Dermatology And Skin Centre
Belize City, Belize
Dr. Moguel's Clinic
Belize City, Belize
Canada, Ontario
K. Papp Clinical Research, Inc.
Waterloo, Ontario, Canada, N2J 1C4
Windsor Clinical Research Center, Inc.
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Innovaderm Research, Inc.
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00689117     History of Changes
Other Study ID Numbers: 114681, W0265-03
Study First Received: May 24, 2008
Results First Received: November 2, 2010
Last Updated: September 22, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Acne Vulgaris
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Tretinoin
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014