Rifaximin Treatment of Papulopustular Rosacea

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Rosacea
• Intervention / Treatment: Drug: Rifaximin (XIFAXAN); Drug: Placebo

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF, CTSI, 12-Moffitt/Long Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rifaximin; rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days	Drug: Rifaximin (XIFAXAN); Rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days; Other Names: XIFAXAN
Placebo Comparator: sugar pill; Placebo 1 tablet three times a day for 14 days.	Drug: Placebo; Placebo 1 tablet three times a day for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator's Global Assessment (IGA) Score of Rosacea Symptoms	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.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achieving an IGA score of 0.	Percentage of patients achieving an IGA score of '0' (cleared).	14 days

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Martin Steinhoff, MD, Ph.D., UCSF, Dept. of Dermatology

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: April 1, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Estimate): April 28, 2014
• Last Update Submitted That Met QC Criteria: April 25, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Rosacea
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin
• Other Study ID Numbers: Salix Rifaximin Study