Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 171
- Primary Endpoint
- Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12
Study Overview
Brief Summary
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe facial acne vulgaris
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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, 3 or more nodules and/or cysts (diameter of 1cm or greater). 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
Arms & Interventions
1
Dapsone Gel 5% and Tazarotene Cream 0.1%
Intervention: Dapsone (Drug)
2
Tazarotene Cream 0.1%
Intervention: Tazarotene (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12
Time Frame: Baseline, Week 12
Change from baseline in inflammatory lesion count (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).
Secondary Outcomes
- Change From Baseline in Investigator Global Assessment at Week 12(Baseline, Week 12)
- Change From Baseline in Overall Disease Severity at Week 12(Baseline, Week 12)
- Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12(Baseline, Week 12)