Rifaximin Treatment of Papulopustular Rosacea
This study is not yet open for participant recruitment.
Verified February 2013 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01359228
First received: April 1, 2011
Last updated: February 5, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rosacea |
Drug: Rifaximin (XIFAXAN) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Rifaximin Treatment of Papulopustular Rosacea: Double- Blinded, Placebo-Controlled, Crossover Study |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Investigator's Global Assessment (IGA) Score of Rosacea Symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]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. [ Time Frame: 14 days ] [ Designated as safety issue: No ]Percentage of patients achieving an IGA score of '0' (cleared).
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rifaximin
rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days
|
Drug: Rifaximin (XIFAXAN)
Rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days
Other Name: XIFAXAN
|
|
Placebo Comparator: sugar pill
Placebo 1 tablet three times a day for 14 days.
|
Drug: Placebo
Placebo 1 tablet three times a day for 14 days.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359228
Contacts
| Contact: Martin Steinhoff, MD, Ph.D. | 415-885-7622 | steinhoffm@derm.ucsf.edu |
| Contact: Elaine Yu | 415-885-7622 | yue@derm.ucsf.edu |
Locations
| United States, California | |
| UCSF, CTSI, 12-Moffitt/Long Hospital | Not yet recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Deanna Sheeley 415-353-1330 dsheeley@gcrc.ucsf.edu | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Martin Steinhoff, MD, Ph.D. | UCSF, Dept. of Dermatology |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01359228 History of Changes |
| Other Study ID Numbers: | Salix Rifaximin Study |
| Study First Received: | April 1, 2011 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, San Francisco:
|
Rosacea |
Additional relevant MeSH terms:
|
Rosacea Skin Diseases Rifaximin Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 18, 2013