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

Papulopustular Rosacea Clinical Trial

Official title:

A Phase IIa, Multicenter, Double Blind, Placebo Controlled, Randomized Clinical Trial to Assess Safety, Efficacy and Pharmacokinetics of Rifaximin Delayed-Release (Rifaximin-EIR) in Patients With Moderate-to-severe Papulopustular Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05150587
• Other study ID #: RE-ROS2002-2021
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

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