NCT05150587

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Alfasigma S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Rifaximin	Rifaximin tablets
DRUG	Placebo	Placebo tablets

Timeline

• Start date: 2021-10-05
• Primary completion: 2022-10-20
• Completion: 2022-10-20
• First posted: 2021-12-09
• Last updated: 2024-04-24
• Results posted: 2024-04-24

Locations

38 sites across 1 country: United States

Regulatory

• FDA-regulated drug study