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ACZONE (DAPSONE): CLINICAL STUDIES
Two randomized, double blind, vehicle controlled, clinical studies were conducted to evaluate Aczone gel 5% for the treatment of patients with acne vulgaris (N=1475 and 1525). The studies were designed to enroll patients 12 years of age and older with 20 to 50 inflammatory and 20 to 100 noninflammatory lesions at baseline. In these studies patients applied either Aczone (Dapsone) gel or vehicle control twice daily for up to 12 weeks. Efficacy was evaluated in terms of success on the Global Acne Assessment Score (no or minimal acne) and in the percent reduction in inflammatory, non-inflammatory, and total lesions.
The Global Acne Assessment Score was a 5-point scale as follows:
None: no evidence of facial acne vulgaris
Minimal: few non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) may be present
Mild: several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present
Moderate: many non-inflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
Severe: significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulocystic lesions may be present; comedones may be present.
The clinical studies enrolled about equal proportions of male and female subjects. Female patients tended to have greater percent reductions in lesions and greater success on the Global Acne Assessment Score than males. The breakdown by race in the clinical studies was about 73% Caucasian, 14% Black, 9% Hispanic, and 2% Asian. Efficacy results were similar across the racial subgroups.
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