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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris; Acne
• Intervention / Treatment: Drug: CT Gel; Drug: Clindamycin Gel (clindamycin ); Drug: Tretinoin Gel (tretinoin); Drug: Vehicle Gel

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: Interventional
• Enrollment (Actual): 1649
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)	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.	Baseline, Week 12
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	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.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at 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.	Baseline, Week 12
The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at 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.	Week 12
The Percentage of Participants Who Had ISGA Scores of 0 or 1 at 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.	Week 12

Collaborators and Investigators

• Sponsor: Stiefel, a GSK Company
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: May 24, 2008
• First Submitted That Met QC Criteria: June 2, 2008
• First Posted (Estimate): June 3, 2008

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Acne; Acne Vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Keratolytic Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin
• Other Study ID Numbers: 114681; W0265-03 (Other Identifier: Stiefel)