Rosacea Clinical Trial
Official title:
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
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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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