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Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
NCT05150587 · View on ClinicalTrials.gov ↗
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: 1. To explore the safety and efficacy of 2 doses of oral Rifaximin versus placebo in adults with moderate-to-severe papulopustular rosacea. 2. To assess the pharmacokinetics (PK) of these two dose regimens in a sub-group of patients.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rifaximin
Study Locations (20)
California
- Long Beach Clinical Trials — Long Beach
- Metropolis Dermatology — Los Angeles
- LA Universal Research Center — Los Angeles
- Cosmetic Laser Dermatology — San Diego
- UCSD — San Diego
- University Clinical Trials, Inc. — San Diego
Florida
- Skin Care Research — Boca Raton
- MOORE Clinical Research,Inc. — Brandon
- Sweet Hope Research Specialty, Inc. — Hialeah
- Savin Medical Group — Miami Lakes
- Leavitt Medical Associates of Florida — Ormond Beach
Louisiana
- Delricht Research Baton Rouge LA — Baton Rouge
- Delricht Research Covington LA — Covington
- DelRicht Research Houma Louisiana — Houma
Kentucky
- Skin Science PLLC — Louisville
- DS Research — Louisville
Arizona
- Dermatology Research Ventures — Yuma
Arkansas
- Johnson Dermatology — Fort Smith
Georgia
- DelRicht Research — Marietta
Indiana
- DS Research — Clarksville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2022-10-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05150587
The ClinicalTrials.gov registry entry for NCT05150587 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alfasigma S.p.A., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Papulopustular Rosacea appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05150587 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05150587 about?
NCT05150587 is a clinical study titled "Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea". 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, particu...
What is the current status of trial NCT05150587?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2021-10-05. Estimated completion is 2022-10-20.
What conditions does trial NCT05150587 study?
This clinical trial studies the following conditions: Papulopustular Rosacea. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05150587?
The interventions under investigation include: Placebo (DRUG), Rifaximin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05150587?
This trial is sponsored by Alfasigma S.p.A., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05150587 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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