Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 24, 2008
September 22, 2011
April 2008
April 2009   (final data collection date for primary outcome measure)
  • 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.
Co-Primary Endpoints:The absolute change in lesion counts (total, inflammatory, non-inflammatory) from baseline to week 12.; the proportion of subjects who have a minimum two grade improvement in ISGA score from baseline to week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00689117 on ClinicalTrials.gov Archive Site
  • 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.
  • The percent (%) change in lesion counts (total, inflammatory, non-inflammatory) from baseline to week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • The proportion of subjects who have a SGA score of 0 or 1 at week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acne Vulgaris
  • Acne
  • Drug: CT Gel
    Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
  • Drug: Clindamycin Gel (clindamycin )
    Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
  • Drug: Tretinoin Gel (tretinoin)
    Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
  • Drug: Vehicle Gel
    Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks
  • Experimental: 1
    CT Gel
    Intervention: Drug: CT Gel
  • Active Comparator: 2
    Clindamycin Gel (clindamycin)
    Intervention: Drug: Clindamycin Gel (clindamycin )
  • Active Comparator: 3
    Tretinoin Gel (tretinoin)
    Intervention: Drug: Tretinoin Gel (tretinoin)
  • Placebo Comparator: 4
    Vehicle Gel
    Intervention: Drug: Vehicle Gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1649
May 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belize,   Canada
 
NCT00689117
114681, W0265-03
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
Stiefel, a GSK Company
GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP