Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00689117
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : December 2, 2010
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Tracking Information
First Submitted Date  ICMJE May 24, 2008
First Posted Date  ICMJE June 3, 2008
Results First Submitted Date  ICMJE November 2, 2010
Results First Posted Date  ICMJE December 2, 2010
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE April 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2010)
  • Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) [ Time Frame: Baseline, Week 12 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2008)
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 ]
Change History Complete list of historical versions of study NCT00689117 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2010)
  • Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 [ Time Frame: Baseline, Week 12 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2008)
  • The percent (%) change in lesion counts (total, inflammatory, non-inflammatory) from baseline to week 12. [ Time Frame: Week 12 ]
  • The proportion of subjects who have a SGA score of 0 or 1 at week 12. [ Time Frame: Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acne Vulgaris
  • Acne
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2010)
1649
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2008)
1652
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belize,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00689117
Other Study ID Numbers  ICMJE 114681
W0265-03 ( Other Identifier: Stiefel )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline ( Stiefel, a GSK Company )
Study Sponsor  ICMJE Stiefel, a GSK Company
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2017

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