Back to resultsCombination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
adapalene gel, 0.3%
clindamycin/benzoyl peroxide gel
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Subjects with a minimum of 20 inflammatory lesions on the face;
- Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
- Subject has a Global Severity Assessment
Exclusion Criteria:
1. Subjects with more than three nodulo-cystic lesions
Sites / Locations
- Center for Dermatology and Laser Surgery
- Derm Research, P.L.L.C.
- Brodell Medical
- Northwest Cutaneous Research Specialists
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Treatment
Arm Description
adapalene gel, 0.3% Other Names: Differin® Gel, 0.3% Applied once daily at bedtime clindamycin/benzoyl peroxide gel Other Names: Duac® Gel Applied once daily in the morning
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Total Lesion Counts
Secondary Outcome Measures
Global Severity Assessment Success
Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear
Global Assessment of Improvement From Baseline
Worst Post Baseline Tolerability Assessment - Erythema
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Worst Post Baseline Tolerability Assessment - Scaling
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Worst Post Baseline Tolerability Assessment - Dryness
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Worst Post Baseline Tolerability Assessment - Burning/Stinging
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00671749
Brief Title
Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
Official Title
A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.
Detailed Description
Same as above.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Treatment
Arm Type
Experimental
Arm Description
adapalene gel, 0.3%
Other Names:
Differin® Gel, 0.3% Applied once daily at bedtime
clindamycin/benzoyl peroxide gel
Other Names:
Duac® Gel Applied once daily in the morning
Intervention Type
Drug
Intervention Name(s)
adapalene gel, 0.3%
Other Intervention Name(s)
Differin® Gel, 0.3%
Intervention Description
Applied once daily at bedtime
Intervention Type
Drug
Intervention Name(s)
clindamycin/benzoyl peroxide gel
Other Intervention Name(s)
Duac® Gel
Intervention Description
Applied once daily in the morning
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Total Lesion Counts
Time Frame
6 and 12 weeks
Secondary Outcome Measure Information:
Title
Global Severity Assessment Success
Description
Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear
Time Frame
6 and 12 weeks
Title
Global Assessment of Improvement From Baseline
Time Frame
12 weeks
Title
Worst Post Baseline Tolerability Assessment - Erythema
Description
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame
12 weeks
Title
Worst Post Baseline Tolerability Assessment - Scaling
Description
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame
12 weeks
Title
Worst Post Baseline Tolerability Assessment - Dryness
Description
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame
12 weeks
Title
Worst Post Baseline Tolerability Assessment - Burning/Stinging
Description
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a minimum of 20 inflammatory lesions on the face;
Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
Subject has a Global Severity Assessment
Exclusion Criteria:
1. Subjects with more than three nodulo-cystic lesions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron W Gottschalk, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Center for Dermatology and Laser Surgery
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Derm Research, P.L.L.C.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Brodell Medical
City
Warren
State/Province
Ohio
ZIP/Postal Code
44483
Country
United States
Facility Name
Northwest Cutaneous Research Specialists
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
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