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Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea

NCT05150587 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2024-04-24

Study results available
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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

  • Papulopustular Rosacea

Interventions

DRUG

Rifaximin

Rifaximin tablets

DRUG

Placebo

Placebo tablets

Sponsors & Collaborators

  • bioRASI, LLC

    collaborator INDUSTRY

  • Alfasigma S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2022-10-20
Completion
2022-10-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05150587 on ClinicalTrials.gov