Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
Completed · Phase 2 · Has a placebo group
Conditions studied: Papulopustular Rosacea
In brief
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.
Key facts
- Study ID
- NCT05150587
- Run by
- Alfasigma S.p.A.
- People needed
- 216
- Starts
- 2021-10-05
- Expected to finish
- 2022-10-20
- Last updated by the study team
- 2024-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Dermatology Research Ventures — Yuma, Arizona, United States
- Johnson Dermatology — Fort Smith, Arkansas, United States
- Long Beach Clinical Trials — Long Beach, California, United States
- Metropolis Dermatology — Los Angeles, California, United States
- LA Universal Research Center — Los Angeles, California, United States
- Cosmetic Laser Dermatology — San Diego, California, United States
- UCSD — San Diego, California, United States
- University Clinical Trials, Inc. — San Diego, California, United States
- Skin Care Research — Boca Raton, Florida, United States
- MOORE Clinical Research,Inc. — Brandon, Florida, United States
- Sweet Hope Research Specialty, Inc. — Hialeah, Florida, United States
- Savin Medical Group — Miami Lakes, Florida, United States
- Leavitt Medical Associates of Florida — Ormond Beach, Florida, United States
- DelRicht Research — Marietta, Georgia, United States
- DS Research — Clarksville, Indiana, United States
- Skin Science PLLC — Louisville, Kentucky, United States
- DS Research — Louisville, Kentucky, United States
- Delricht Research Baton Rouge LA — Baton Rouge, Louisiana, United States
- Delricht Research Covington LA — Covington, Louisiana, United States
- DelRicht Research Houma Louisiana — Houma, Louisiana, United States
- DelRicht Research — New Orleans, Louisiana, United States
- Revival Research Institute, LLC. — Troy, Michigan, United States
- Grekin Skin Care Institute — Wyandotte, Michigan, United States
- MediSearch Clinical Trials — Saint Joseph, Missouri, United States
- JDR Dermatology Research — Las Vegas, Nevada, United States
Full record on ClinicalTrials.gov
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