Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris

Study Overview
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Brief Summary
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A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Dapsone; Tretinoin
* Drug: Tretinoin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Facial acne vulgaris characterized by the following: 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions; Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm) Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study Exclusion Criteria: Non-compliance with washout period; History of clinically significant anemia or hemolysis; Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris; Allergy or sensitivity to any component of the test medications

Ages Eligible for Study
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Minimum Age: 12 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Dapsone gel 5% and Tretinoin gel 0.025% | Drug: Dapsone; Tretinoin<br>* Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks<br>* Other names: Aczone Gel 5%; Tretin-X Gel 0.025%;|
| Active Comparator: 2<br>Tretinoin gel 0.025% | Drug: Tretinoin<br>* Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks<br>* Other names: Tretin-X Gel 0.025%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement). | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Investigator Global Assessment at Week 12 | Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement). | Baseline, Week 12 | 
| Change From Baseline in Overall Disease Severity at Week 12 | Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement). | Baseline, Week 12 | 
| Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement). | Baseline, Week 12 |