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

Allergan163 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

163

Conditions

Acne Vulgaris

Interventions

Dapsone; TretinoinDRUG

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

TretinoinDRUG

Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Strongsville, Ohio, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline, Week 12

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Data from ClinicalTrials.gov

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