Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

This is a multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to
assess the safety and efficacy of dapsone 7.5% gel versus vehicle administered topically once
daily for 12 weeks in patients with acne vulgaris.

Inclusion Criteria:

- Diagnosis of acne vulgaris

- Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight,
tanning beds) throughout the study

Exclusion Criteria:

- Severe cystic acne, acne conglobata, acne fulminans, or secondary acne

- Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive
cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling,
comedo extraction) in the past week

- Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics,
antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]),
retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps
such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium
sulfacetamide) in the past 2 weeks

- Use of birth control pills strictly for acne control