Viewing Study NCT00249782



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Study NCT ID: NCT00249782
Status: COMPLETED
Last Update Posted: 2011-05-30
First Post: 2005-11-03

Brief Title: A Phase II Randomized Study of ACZONE Dapsone Gel 5 for Papulopustular Rosacea
Sponsor: Allergan
Organization: Allergan

Study Overview

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
Status: COMPLETED
Status Verified Date: 2011-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None