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Withdrawn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
About this trial
This is an interventional treatment trial for Rosacea focused on measuring Rosacea
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
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Withdrawn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
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
Learn more about this trial
Rifaximin Treatment of Papulopustular Rosacea
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