Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
- Registration Number
- NCT05150587
- Lead Sponsor
- Alfasigma S.p.A.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
- 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
- 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 ulcers.
- History of coeliac disease.
- Patients with intestinal obstruction or partial intestinal obstruction.
- Presence of diarrhoea associated with fever and/or blood in the stool.
- Severe kidney impairment (i.e. estimated glomerular filtration rate <30 ml/min).
- Severe hepatic impairment (i.e. Child-Pugh B or C).
- Cancer or any cancer-related treatment within 5 years prior to screening (excluding non-melanoma skin-cancer).
- History of alcohol or drug abuse within a year prior to screening, based on Investigator's judgement.
- Facial skin conditions that can interfere with reliable assessment of rosacea throughout the study (e.g. facial hair, tattoos, other facial adornments, keloids, hypertrophic scarring, recent facial surgery, excessive sun exposure including use of tanning beds)
- Any other significant health condition (e.g. cardiovascular, respiratory, renal, hepatic, neurologic, psychiatric, hematologic, oncologic, immune etc.) or non-health condition that in the investigator's judgement may: i) jeopardize the patient's safe participation in the trial or ii) make unlikely the patient's completion of the study or iii) make unlikely the patient's compliance with the study procedures (e.g. highly anticipated need of non-permitted treatments, terminal illness, etc.).
- History of hypersensitivity to the study drug.
- Treatment with biologic immunomodulatory and/or immunosuppressive drugs (e.g. anti-tumor necrosis factor [TNF] drugs) within 6 months prior to randomization.
- Treatment with non-biologic immunomodulatory and/or immunosuppressive drugs (e.g. cyclosporine, methotrexate etc.) within 30 days prior to randomization.
- Treatment with warfarin (or other coumarins) within 14 days prior to randomization.
- Treatment with niacin within 30 days prior to randomization.
- Topical facial or systemic antibiotics within 30 days before randomization;
- Treatment with neomycin or other low-absorbable oral antibiotics within 90 days before randomization.
- Topical facial, inhaled or systemic corticosteroids within 30 days prior to randomization.
- Topical facial retinoids within 30 days before randomization.
- Systemic retinoids within 6 months before randomization.
- Any other topical or systemic treatment for rosacea within 30 days before randomization (including also laser and pulsed light, etc.).
- Over-the-counter intestinal or topical skin probiotics (functional food is allowed), within 30 days before randomization.
- Any experimental treatment within 6 months prior to randomization.
- Current swab-positive or suspected (under investigation) Covid-19 infection; or fever and one or more of the following respiratory disease signs or symptoms: cough, sputum production, shortness of breath within the last 14 days; or contact with people with Covid-19 infection within the last 14 days.
- Women who are pregnant, breast-feeding or planning a pregnancy during the trial period.
- Subjects who are investigational site staff members and their family members, site staff members otherwise supervised by the investigator, or patients who are Alfasigma's employees.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rifaximin 250 mg TID Rifaximin - Rifaximin 500 mg TID Rifaximin - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Co-primary Endpoint: Change From Baseline in Number of Rosacea Inflammatory Lesions 30 days 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 0 or 1 (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe) at the end of treatment.Co-primary Endpoint: Treatment Success Rate 30 days 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 0 or 1 (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe) at the end of treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Skin Care Research
🇺🇸Boca Raton, Florida, United States
Metropolis Dermatology
🇺🇸Los Angeles, California, United States
DelRicht Research
🇺🇸Tulsa, Oklahoma, United States
Dermatology Research Ventures
🇺🇸Yuma, Arizona, United States
MOORE Clinical Research,Inc.
🇺🇸Brandon, Florida, United States
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
LA Universal Research Center
🇺🇸Los Angeles, California, United States
3A Research
🇺🇸El Paso, Texas, United States
Paddington Testing Co, Inc
🇺🇸Philadelphia, Pennsylvania, United States
Cosmetic Laser Dermatology
🇺🇸San Diego, California, United States
JDR Dermatology Research
🇺🇸Las Vegas, Nevada, United States
UCSD
🇺🇸San Diego, California, United States
University Clinical Trials, Inc.
🇺🇸San Diego, California, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Johnson Dermatology
🇺🇸Fort Smith, Arkansas, 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 Houma Louisiana
🇺🇸Houma, Louisiana, United States
Delricht Research Covington LA
🇺🇸Covington, Louisiana, United States
Delricht Research Baton Rouge LA
🇺🇸Baton Rouge, Louisiana, United States
Revival Research Institute, LLC.
🇺🇸Troy, Michigan, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Grekin Skin Care Institute
🇺🇸Wyandotte, Michigan, United States
Onsite Clinical Solutions
🇺🇸Charlotte, North Carolina, United States
Dermatology Consulting Services, PLLC
🇺🇸High Point, North Carolina, United States
JUVA Skin and Laser Center
🇺🇸New York, New York, United States
DelRicht Research Frisco Texas
🇺🇸Frisco, Texas, United States
Austin Institute for Clinical Research
🇺🇸Pflugerville, Texas, United States
Velocity Clinical Research
🇺🇸Salt Lake City, Utah, United States
Dermatology Treatment and Research Center
🇺🇸Dallas, Texas, United States
DS Research
🇺🇸Louisville, Kentucky, United States
Skin Science PLLC
🇺🇸Louisville, Kentucky, United States
West End Dermatology Associates
🇺🇸Richmond, Virginia, United States