Back to resultsA Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
Primary Purpose
Acne Vulgaris, Acne
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CT Gel
Clindamycin Gel (clindamycin )
Tretinoin Gel (tretinoin)
Vehicle Gel
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Acne
Eligibility 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.
Sites / Locations
- Radiant Research
- Coastal Clinical Research, Inc.
- Burke Pharmaceutical Research
- Center for Dermatology, Cosmetic and Laser Surgery
- University Clinical Trials
- Longmont Medical Research Network
- FXM Research Corporation
- FXM Research - Miramar
- Advanced Dermatolgy & Cosemtic Surgery
- Dermatology Specialists
- Massachusettes General Hospital - Clinical Unit for Research Trials in Skin
- University of Michigan
- Henry Ford Medical Center
- Minnesota Clinical Study Center
- Skin Specialists, P.C.
- Academic Dermatology Research
- Dermatology Research Associates, Inc.
- Yardley Dermatology Associates
- Clinical Partners, LLC
- Dermatology Associates of Knoxville, P.C.
- Tennessee Clinical Research
- DermResearch, Inc.
- J & S Studies, Inc.
- The Hair and Skin Research Treatment Center
- Dermatology Research Center, Inc.
- Premier Clincial Research
- Advanced Healthcare
- Dermatology And Skin Centre
- Dr. Moguel's Clinic
- K. Papp Clinical Research, Inc.
- Windsor Clinical Research Center, Inc.
- Innovaderm Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
CT Gel
Clindamycin Gel (clindamycin)
Tretinoin Gel (tretinoin)
Vehicle Gel
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT00689117
First Posted
May 24, 2008
Last Updated
May 25, 2017
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00689117
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Acne
Keywords
Acne Vulgaris, Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1649 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
CT Gel
Arm Title
2
Arm Type
Active Comparator
Arm Description
Clindamycin Gel (clindamycin)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Tretinoin Gel (tretinoin)
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Vehicle Gel
Intervention Type
Drug
Intervention Name(s)
CT Gel
Intervention Description
Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Clindamycin Gel (clindamycin )
Intervention Description
Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Tretinoin Gel (tretinoin)
Intervention Description
Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Intervention Description
Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
Description
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.
Time Frame
Baseline, Week 12
Title
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
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12
Description
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.
Time Frame
Week 12
Title
The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12
Description
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.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
33608
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Center for Dermatology, Cosmetic and Laser Surgery
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
University Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
FXM Research Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
FXM Research - Miramar
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Advanced Dermatolgy & Cosemtic Surgery
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Massachusettes General Hospital - Clinical Unit for Research Trials in Skin
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Skin Specialists, P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Academic Dermatology Research
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Dermatology Research Associates, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45230
Country
United States
Facility Name
Yardley Dermatology Associates
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Dermatology Associates of Knoxville, P.C.
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Tennessee Clinical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J & S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77840
Country
United States
Facility Name
The Hair and Skin Research Treatment Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Dermatology Research Center, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Premier Clincial Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Advanced Healthcare
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Dermatology And Skin Centre
City
Belize City
Country
Belize
Facility Name
Dr. Moguel's Clinic
City
Belize City
Country
Belize
Facility Name
K. Papp Clinical Research, Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Windsor Clinical Research Center, Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Innovaderm Research, Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
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