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Rifaximin Treatment of Papulopustular Rosacea

Primary Purpose

Rosacea

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Rifaximin (XIFAXAN)

Placebo

About this trial

This is an interventional treatment trial for Rosacea focused on measuring Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UCSF, CTSI, 12-Moffitt/Long Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rifaximin

sugar pill

Arm Description

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

Placebo 1 tablet three times a day for 14 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Achieving an IGA score of 0.

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

Full Information

NCT ID

NCT01359228

First Posted

April 1, 2011

Last Updated

April 25, 2014

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT01359228

Brief Title

Rifaximin Treatment of Papulopustular Rosacea

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Withdrawn

Study Start Date

April 2013 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosacea

Keywords

Rosacea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rifaximin

Arm Type

Experimental

Arm Description

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

Arm Title

sugar pill

Arm Type

Placebo Comparator

Arm Description

Placebo 1 tablet three times a day for 14 days.

Intervention Type

Drug

Intervention Name(s)

Rifaximin (XIFAXAN)

Other Intervention Name(s)

XIFAXAN

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo 1 tablet three times a day for 14 days.

Primary Outcome Measure Information:

Title

Investigator's Global Assessment (IGA) Score of Rosacea Symptoms

Description

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.

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Achieving an IGA score of 0.

Description

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

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Steinhoff, MD, Ph.D.

Organizational Affiliation

UCSF, Dept. of Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSF, CTSI, 12-Moffitt/Long Hospital

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Rifaximin Treatment of Papulopustular Rosacea

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