Rifaximin Treatment of Papulopustular Rosacea

Phase 2

Withdrawn

• Conditions: Rosacea
• Interventions: Drug: Placebo; Drug: Rifaximin (XIFAXAN)

• Registration Number: NCT01359228
• Lead Sponsor: University of California, San Francisco

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 Description

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.

Study Timeline

• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Study Start: 2013-04
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-25
• Last Update Posted: 2014-04-28
• Primary Completion: 2014-06
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Males and females
• > 18 years of age with rosacea defined as:
• 3-40 papules/pustules and < 2 nodules,
• A score of 2-4 on the Investigator Global Assessment

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Exclusion Criteria

• Untreated pancreatic insufficiency
• Crohn's disease
• Ulcerative colitis
• Active celiac disease by clinical history
• End stage renal failure
• Less than 18 years old
• Pregnancy or positive pregnancy test
• Rosacea subtype 1 (no papules )
• Topical or oral antibiotics within 4 weeks
• Acne treatments within 4 weeks prior to randomization
• Systemic retinoids within 90 days
• Topical or systemic corticosteroids 4 weeks prior to randomization

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sugar pill	Placebo	Placebo 1 tablet three times a day for 14 days.
Rifaximin	Rifaximin (XIFAXAN)	rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days

Primary Outcome Measures

Name	Time	Method
Investigator's Global Assessment (IGA) Score of Rosacea Symptoms	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.

Secondary Outcome Measures

Name	Time	Method
Achieving an IGA score of 0.	14 days	Percentage of patients achieving an IGA score of '0' (cleared).

Trial Locations

Locations (1)

UCSF, CTSI, 12-Moffitt/Long Hospital; 🇺🇸 San Francisco, California, United States