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”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • CT Gel
• Active Comparator: 2
  • Clindamycin Gel (clindamycin)
• Active Comparator: 3
  • Tretinoin Gel (tretinoin)
• Placebo Comparator: 4
  • Vehicle Gel

Primary Measures

• Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
  • Time Frame: Baseline, Week 12
    Safety Issue?: No
• 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
    Safety Issue?: No

Secondary Measures

• Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
  • Time Frame: Baseline, Week 12
    Safety Issue?: No
• The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12
  • Time Frame: Week 12
    Safety Issue?: No
• The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12
  • Time Frame: Week 12
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Stiefel, a GSK Company Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00689117

Study ID Number: 114681

ClinicalTrials.gov Identifier: NCT00689117

Health Authority: Canada: Health Canada