Rifaximin Treatment of Papulopustular Rosacea

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rosacea

Intervention / Treatment
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* Drug: Rifaximin (XIFAXAN)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rosacea