Study Results
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2013-04-30
2014-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Rifaximin
rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days
Rifaximin (XIFAXAN)
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.
Placebo
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
Placebo
Placebo 1 tablet three times a day for 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \> 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
* 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
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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Salix Rifaximin Study
Identifier Type: -
Identifier Source: org_study_id
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