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Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test

NCT03864978 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2019-03-11

No results posted yet for this study

Summary

Preliminary evidence suggests that treatment with rifaximin may be beneficial in patients with papulopustular rosacea.

The present clinical trial is aimed to investigate the safety and efficacy of oral rifaximin delayed release versus placebo in adults with moderate-to-severe papulopustular rosacea (a.k.a. subtype II) and positive lactulose H2/CH4 breath test.

Conditions

  • Papulopustular Rosacea

Interventions

DRUG

Rifaximin delayed release 400 mg tablet

Rifaximin delayed release

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Alfasigma S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-22
Primary Completion
2020-04-30
Completion
2020-10-31

Countries

  • Italy

Study Locations

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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 NCT03864978 on ClinicalTrials.gov