Rifaximin Treatment of Papulopustular Rosacea
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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