Rifaximin Treatment of Papulopustular Rosacea

NCT ID: NCT01359228

Last Updated: 2014-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

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.

Conditions

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rifaximin

rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days

Group Type EXPERIMENTAL

Rifaximin (XIFAXAN)

Intervention Type DRUG

Rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days

sugar pill

Placebo 1 tablet three times a day for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1 tablet three times a day for 14 days.

Interventions

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Rifaximin (XIFAXAN)

Rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days

Intervention Type DRUG

Placebo

Placebo 1 tablet three times a day for 14 days.

Intervention Type DRUG

Other Intervention Names

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XIFAXAN

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Steinhoff, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UCSF, Dept. of Dermatology

Locations

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UCSF, CTSI, 12-Moffitt/Long Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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Salix Rifaximin Study

Identifier Type: -

Identifier Source: org_study_id

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