A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.

Summary

The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea. ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA. Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12.

Timeline

Start

2005-11

Primary completion

2006-05

Completion

2006-05

Drugs

Indications