Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
Overview
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.
Full Title of Study: “A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: August 2008
Detailed Description
Same as above.
Interventions
- Drug: adapalene gel, 0.3%
- Applied once daily at bedtime
- Drug: clindamycin/benzoyl peroxide gel
- Applied once daily in the morning
Arms, Groups and Cohorts
- Experimental: Study Treatment
- 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
Clinical Trial Outcome Measures
Primary Measures
- Percent Change From Baseline in Total Lesion Counts
- Time Frame: 6 and 12 weeks
Secondary Measures
- Global Severity Assessment Success
- Time Frame: 6 and 12 weeks
- 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
- Time Frame: 12 weeks
- Worst Post Baseline Tolerability Assessment – Erythema
- Time Frame: 12 weeks
- 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
- Time Frame: 12 weeks
- 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
- Time Frame: 12 weeks
- 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
- Time Frame: 12 weeks
- 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.
Participating in This Clinical Trial
Inclusion Criteria
1. Subjects with a minimum of 20 inflammatory lesions on the face; 2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose; 3. Subject has a Global Severity Assessment Exclusion Criteria:
1. Subjects with more than three nodulo-cystic lesions
Gender Eligibility: All
Minimum Age: 12 Years
Maximum Age: 35 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Galderma R&D
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Ron W Gottschalk, MD, Study Director, Galderma R&D
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