• Investigator global assessment [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
• Overall disease severity [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
• Inflamed lesion counts (nodules) [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
• Non-inflamed lesion counts (open/closed comedones) [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]

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

• Drug: Dapsone
  Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks
  Other Name: Aczone Gel 5%; Tazorac Cream 0.1%
• Drug: Tazarotene
  Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks
  Other Name: Tazorac Cream 0.1%

• 1: Active Comparator
  Dapsone Gel 5% and Tazarotene Cream 0.1%
  Intervention: Drug: Dapsone
• 2: Active Comparator
  Tazarotene Cream 0.1%
  Intervention: Drug: Tazarotene

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