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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Withdrawn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
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
April 1, 2011
Last Updated
April 25, 2014
Sponsor
University of California, San Francisco
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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
No

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
No
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

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Rifaximin Treatment of Papulopustular Rosacea

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