Clinical Trial: Rifaximin Treatment of Papulopustular Rosacea

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Rifaximin Treatment of Papulopustular Rosacea: Double- Blinded, Placebo-Controlled, Crossover Study

Brief Summary: The purpose of this study is to determine the effects of rifaximin on skin symptoms in patients with rosacea by double-blinded, placebo-controlled, crossover study.

Detailed Summary:

100 patients will be randomized into two groups.

Group A will receive one rifaximin 550 mg tablet three times a day (1650 mg/day) for 14 days, and after a 4-week washout period, receive one placebo tablet three times a day for 14 days.

Group B will receive placebo first, and then rifaximin with the same dosage schedule to Group A.

Assessments will be performed before application and 4 weeks after the last dosage, for both of rifaximin and placebo.


Sponsor: University of California, San Francisco

Current Primary Outcome: Investigator's Global Assessment (IGA) Score of Rosacea Symptoms [ Time Frame: 14 days ]

A response to treatment is defined as the achievement of an IGA score of '0 or 1' at endpoint for moderate to severe patients and achievement of an IGA score of '0' at endpoint for mild patients.


Original Primary Outcome: Same as current

Current Secondary Outcome: Achieving an IGA score of 0. [ Time Frame: 14 days ]

Percentage of patients achieving an IGA score of '0' (cleared).


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: April 1, 2011
Date Started: April 2013
Date Completion: December 2014
Last Updated: April 25, 2014
Last Verified: April 2014