Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Study Overview
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Brief Summary
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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
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Same as above.

Official Title
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A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: adapalene gel, 0.3%
* Drug: clindamycin/benzoyl peroxide gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Treatment<br>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 | Drug: adapalene gel, 0.3%<br>* Applied once daily at bedtime<br>* Other names: Differin® Gel, 0.3%;Drug: clindamycin/benzoyl peroxide gel<br>* Applied once daily in the morning<br>* Other names: Duac® Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Total Lesion Counts |  | 6 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 and 12 weeks | 
| Global Assessment of Improvement From Baseline |  | 12 weeks | 
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| 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. | 12 weeks |