NCT00249782

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

A Phase II, Randomized, Partial-Blind, Parallel-Group, Active- and Vehicle-Controlled, Multicenter Study of the Safety and Efficacy of ACZONE™ (Dapsone) Gel, 5% in Subjects With Papulopustular Rosacea

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Objective: •To evaluate the safety and preliminary efficacy of ACZONE in subjects with papulopustular rosacea Study Population: Approximately 400 male and female subjects will be enrolled at 27 study centers in the United States. Study Treatment: Subjects will be randomized to 1 of 5 treatment regimens. Subjects will receive study medication for 12 weeks. Study participation is 13 weeks (5 clinic visits and 1 telephone follow-up).

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	Vehicle control, 2x/day
DRUG	ACZONE (dapsone) Gel, 5%, 2x/day
DRUG	ACZONE (dapsone) Gel, 5%, 1x/day
DRUG	MetroGel® (metronidazole gel), 1.0% 1x/day
DRUG	ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2005-11-07
• Last updated: 2011-05-30

Locations

26 sites across 1 country: United States