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

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

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