Rifaximin Treatment of Papulopustular Rosacea
| Status: | Completed |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | April 2013 |
| End Date: | December 2014 |
| Contact: | Martin Steinhoff, MD, Ph.D. |
| Email: | steinhoffm@derm.ucsf.edu |
| Phone: | 415-885-7622 |
Rifaximin Treatment of Papulopustular Rosacea: Double- Blinded, Placebo-Controlled, Crossover Study
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.
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.
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.
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
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