CompletedPhase 2

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

United States216 participantsStarted 2021-10-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Main Inclusion Criteria: * Men and women aged 18 years or older at screening. * Female participants are eligible if they are: i) of non-childbearing potential or ii) of childbearing potential with a negative pregnancy test result at screening and randomization AND agreeing to use a highly effective method of contraception until 72 hours after taking the last study treatment dose. * Presence of rosacea, papulopustular phenotype. * Presence of ≥11 and ≤70 facial papules and/or pustules. * Moderate or severe rosacea based on Investigator's Global Assessment based on Investigator's judgement. * Patients accepting to provide and legally capable of providing free and informed consent to all procedures included in the protocol (including the availability to perform a Lactulose Breath Test). Main Exclusion Criteria: * Granulomatous rosacea or rosacea fulminans. * Erythematotelangiectatic, phymatous or ocular rosacea only. Patients with these subtypes associated with papulopustular rosacea can be enrolled. * Rosacea with Investigator's Global Assessment (IGA) grade ≤2 based on Investigator's judgment. * Anticipated need for proctoscopy or colonoscopy within two weeks after lactulose breath test. * Subjects requiring a low galactose diet. * Hypersensitivity or intolerance to lactulose or any excipient of the lactulose reparation to be used for L-BT. * History of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or other conditions characterized by severe intestinal …

What they're measuring

Co-primary Endpoint: Change From Baseline in Number of Rosacea Inflammatory Lesions

Timeframe: 30 days

Co-primary Endpoint: Treatment Success Rate

Timeframe: 30 days

Trial details

NCT IDNCT05150587

SponsorAlfasigma S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-20

Results submitted2024-02-14