At a glance
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A Phase IIa, Multicenter, Double Blind, Placebo Controlled, Randomized Clinical Trial to Assess Safety, Efficacy and Pharmacokinetics of Rifaximin Delayed-Release (Rifaximin-EIR) in Patients With Moderate-to-severe Papulopustular Rosacea
In Brief
A Phase 2 clinical trial evaluating Rifaximin and Placebo for Papulopustular Rosacea. Completed, enrolled 216 participants across 38 sites.
Detailed 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.
Study Details
Timeline
Interventions
Rifaximin tablets
Placebo tablets