A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.
Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
Participant gender:
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.