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

NCT05150587 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RE-ROS2002-2021
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 38

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. 1.To explore the safety and efficacy of 2 doses of oral Rifaximin versus placebo in adults with moderate-to-severe papulopustular rosacea.
2. 2.To assess the pharmacokinetics (PK) of these two dose regimens in a sub-group of patients.

Conditions

Papulopustular Rosacea

Outcome Measures

Primary Outcomes (2)

• 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): 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.

  30 days

• 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): 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.

  30 days

Study Arms (3)

Rifaximin 250 mg TID

ACTIVE COMPARATOR

Drug: Rifaximin

Rifaximin 500 mg TID

ACTIVE COMPARATOR

Drug: Rifaximin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rifaximin DRUG

Rifaximin tablets

Rifaximin 250 mg TID; Rifaximin 500 mg TID

Placebo DRUG

Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alfasigma S.p.A.: lead
• bioRASI, LLC: collaborator

Study Sites (38)

Dermatology Research Ventures

Yuma, Arizona, 85365, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Long Beach Clinical Trials

Long Beach, California, 90806, United States

Location

Metropolis Dermatology

Los Angeles, California, 90017, United States

Location

LA Universal Research Center

Los Angeles, California, 90057, United States

Location

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

UCSD

San Diego, California, 92122, United States

Location

University Clinical Trials, Inc.

San Diego, California, 92123, United States

Location

Skin Care Research

Boca Raton, Florida, 33486, United States

Location

MOORE Clinical Research,Inc.

Brandon, Florida, 33511, United States

Location

Sweet Hope Research Specialty, Inc.

Hialeah, Florida, 33016, United States

Location

Savin Medical Group

Miami Lakes, Florida, 33014, United States

Location

Leavitt Medical Associates of Florida

Ormond Beach, Florida, 32174, United States

Location

DelRicht Research

Marietta, Georgia, 30060, United States

Location

DS Research

Clarksville, Indiana, 47129, United States

Location

Skin Science PLLC

Louisville, Kentucky, 401217, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Delricht Research Baton Rouge LA

Baton Rouge, Louisiana, 70809, United States

Location

Delricht Research Covington LA

Covington, Louisiana, 70433, United States

Location

DelRicht Research Houma Louisiana

Houma, Louisiana, 70360, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Revival Research Institute, LLC.

Troy, Michigan, 48084, United States

Location

Grekin Skin Care Institute

Wyandotte, Michigan, 48192, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 65406, United States

Location

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

JUVA Skin and Laser Center

New York, New York, 10022, United States

Location

Onsite Clinical Solutions

Charlotte, North Carolina, 28277, United States

Location

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

DelRicht Research

Tulsa, Oklahoma, 74114, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Paddington Testing Co, Inc

Philadelphia, Pennsylvania, 19103, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

3A Research

El Paso, Texas, 79925, United States

Location

DelRicht Research Frisco Texas

Frisco, Texas, 75034, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Velocity Clinical Research

Salt Lake City, Utah, 84117, United States

Location

West End Dermatology Associates

Richmond, Virginia, 23233, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Nicola Gargano - Senior Clinical Scientist
• Organization: Alfasigma

nicola.gargano@alfasigma.com

0039 (0)6 91395072

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: December 9, 2021
• Study Start: October 5, 2021
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: April 24, 2024
• Results First Posted: April 24, 2024

Record last verified: 2023-05

Locations

US (38)