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

Phase 4

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Dapsone; Tretinoin; Drug: Tretinoin

• Registration Number: NCT00835198
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2011-09
• Results First Submitted: 2011-09-22
• Results First Submitted QC: 2011-09-22
• Last Update Submitted: 2011-09-22
• Results First Posted: 2011-10-31
• Last Update Posted: 2011-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Dapsone; Tretinoin	Dapsone gel 5% and Tretinoin gel 0.025%
2	Tretinoin	Tretinoin gel 0.025%

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12	Baseline, 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).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Investigator Global Assessment at Week 12	Baseline, 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).
Change From Baseline in Overall Disease Severity at Week 12	Baseline, 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).
Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12	Baseline, 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).