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

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.

Primary Outcome

This is a co-primary endpoint. Success of the study will be declared in any of the active treatment groups if both the co-primary efficacy endpoints (here listed as 1 and 2) will be satisfied (note: the two items may not necessarily occur in the same patient): 1. Mean change from Baseline in number of rosacea inflammatory lesions (papules, pustules or plaques) at the end of treatment; 2. Percent of participants showing treatment success defined as IGA (Investigator's Global Assessment) score of

Conditions Studied

Interventions

• DRUG Placebo
• DRUG Rifaximin

Study Locations (20)