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Rifaximin-Tested dose B for Papulopustular Rosacea

Phase 2
Waitlist Available
Research Sponsored by Alfasigma S.p.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women aged 18 years or older at screening (V1)
Female participants are eligible if they are: i) of non-childbearing potential or ii) of childbearing potential with a negative pregnancy test result at screening and randomization AND agreeing to use a highly effective method of contraception until 72 hours after taking the last study treatment dose.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

Rosacea is a common chronic inflammatory relapsing-remitting skin condition almost exclusively affecting the central area of the face and the eyes. Preliminary evidence suggests that treatment with rifaximin, a poorly absorbed oral antibiotic drug may be beneficial in patients with rosacea, particularly in those with papulopustular phenotype and positivity to Lactulose Breath Test (L-BT). The objective of this study is twofold: To explore the safety and efficacy of 2 doses of oral Rifaximin versus placebo in adults with moderate-to-severe papulopustular rosacea. To assess the pharmacokinetics (PK) of these two dose regimens in a sub-group of patients.

Eligible Conditions
  • Papulopustular Rosacea

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Number of rosacea inflammatory lesions
Treatment success rate

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Rifaximin-Tested dose BActive Control1 Intervention
Group II: Rifaximin-Tested dose AActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Alfasigma S.p.A.Lead Sponsor
19 Previous Clinical Trials
4,757 Total Patients Enrolled
bioRASI, LLCIndustry Sponsor
13 Previous Clinical Trials
3,440 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Leavitt Medical Associates of Florida
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’m always looking for something to treat my rosacea.
PatientReceived no prior treatments
~63 spots leftby Mar 2025