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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin | Experimental | rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days |
|
| sugar pill | Placebo Comparator | Placebo 1 tablet three times a day for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin (XIFAXAN) | Drug | Rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Achieving an IGA score of 0. | Percentage of patients achieving an IGA score of '0' (cleared). | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Steinhoff, MD, Ph.D. | UCSF, Dept. of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF, CTSI, 12-Moffitt/Long Hospital | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo 1 tablet three times a day for 14 days. |
|
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |