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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05150587
Other study ID # RE-ROS2002-2021
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 5, 2021
Est. completion date October 20, 2022

Study information

Verified date May 2023
Source Alfasigma S.p.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date October 20, 2022
Est. primary completion date October 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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


Related Conditions & MeSH terms


Intervention

Drug:
Rifaximin
Rifaximin tablets
Placebo
Placebo tablets

Locations

Country Name City State
United States Delricht Research Baton Rouge LA Baton Rouge Louisiana
United States Skin Care Research Boca Raton Florida
United States MOORE Clinical Research,Inc. Brandon Florida
United States Onsite Clinical Solutions Charlotte North Carolina
United States DS Research Clarksville Indiana
United States Delricht Research Covington LA Covington Louisiana
United States Dermatology Treatment and Research Center Dallas Texas
United States 3A Research El Paso Texas
United States Johnson Dermatology Fort Smith Arkansas
United States DelRicht Research Frisco Texas Frisco Texas
United States Sweet Hope Research Specialty, Inc. Hialeah Florida
United States Dermatology Consulting Services, PLLC High Point North Carolina
United States DelRicht Research Houma Louisiana Houma Louisiana
United States JDR Dermatology Research Las Vegas Nevada
United States Long Beach Clinical Trials Long Beach California
United States LA Universal Research Center Los Angeles California
United States Metropolis Dermatology Los Angeles California
United States DS Research Louisville Kentucky
United States Skin Science PLLC Louisville Kentucky
United States DelRicht Research Marietta Georgia
United States Savin Medical Group Miami Lakes Florida
United States DelRicht Research New Orleans Louisiana
United States JUVA Skin and Laser Center New York New York
United States Leavitt Medical Associates of Florida Ormond Beach Florida
United States Austin Institute for Clinical Research Pflugerville Texas
United States Paddington Testing Co, Inc Philadelphia Pennsylvania
United States Oregon Dermatology and Research Center Portland Oregon
United States West End Dermatology Associates Richmond Virginia
United States MediSearch Clinical Trials Saint Joseph Missouri
United States Velocity Clinical Research Salt Lake City Utah
United States Progressive Clinical Research San Antonio Texas
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 Revival Research Institute, LLC. Troy Michigan
United States DelRicht Research Tulsa Oklahoma
United States Grekin Skin Care Institute Wyandotte Michigan
United States Dermatology Research Ventures Yuma Arizona

Sponsors (2)

Lead Sponsor Collaborator
Alfasigma S.p.A. bioRASI, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Co-primary Endpoint: Change From Baseline in Number of Rosacea Inflammatory Lesions 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):
Mean change from Baseline in number of rosacea inflammatory lesions (papules, pustules or plaques) at the end of treatment;
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.
30 days
Primary Co-primary Endpoint: Treatment Success Rate 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):
Mean change from Baseline in number of rosacea inflammatory lesions (papules, pustules or plaques) at the end of treatment;
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.
30 days
See also
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