Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test

NCT03864978 | Unknown Phase 2

• 2 other identifiers: REROS/001/172017-003722-33
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 12

Brief Summary

Preliminary evidence suggests that treatment with rifaximin may be beneficial in patients with papulopustular rosacea. The present clinical trial is aimed to investigate the safety and efficacy of oral rifaximin delayed release versus placebo in adults with moderate-to-severe papulopustular rosacea (a.k.a. subtype II) and positive lactulose H2/CH4 breath test.

Conditions

Papulopustular Rosacea

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline (day 1) in number of rosacea inflammatory lesions (papules, pustules or plaques) at the end of treatment visit (day 30 ± 1)

  changes in number of lesions

  30 days

• Percent of participants showing treatment success (IGA score of 0 [clear] or 1 [almost clear]) at the end of treatment visit (day 30 ± 1)

  per cent changes in IGA score 0 and 1 patients

  30 days

Secondary Outcomes (11)

• Mean change from Baseline (day 1) in number of rosacea inflammatory lesions at the end of treatment visit (day 30 ± 1) as provided by Canfield Image Analysis

  30 days

• Mean change from Baseline (day 1) in number of inflammatory lesions (papules, pustules or plaques) at day 10 ± 1 and day 60 ± 3

  10 and 60 days

• Percent of participants showing treatment success (i.e. IGA score of 0 or 1) at day 10 ± 1 and day 60 ± 3

  10 and 60 days

• Percent of participants with IGA score of 0 (clear) at day 10 ± 1, day 30 ± 1 and day 60 ± 3

  10, 30 and 60 days

• Mean change from Baseline (day 1) in the following rosacea additional features at day 10 ± 1, day 30 ± 1 and day 60 ± 3: • burning or stinging • telangiectasia • ocular manifestations • phymatous changes

  10, 30 and 60 days

Other Outcomes (2)

• Mean change from Baseline (day 1) in circulating inflammatory marker levels at 10 ± 1, day 30 ± 1 and day 60 ± 3

  10, 30 and 60 days

• Mean change from baseline (day 1) skin texture index at 10 ± 1, day 30 ± 1 and day 60 ± 3 as provided by Canfield Image Analysis

  10, 30 and 60 days

Study Arms (4)

Rifaximin-EIR 800 mg BID for 10 days

EXPERIMENTAL

2 x rifaximin delayed release 400 mg tablet twice a day (total daily dose of rifaximin: 1600 mg) for 10 days and 2 x placebo tablets twice a day for the following 20 days

Drug: Rifaximin delayed release 400 mg tablet; Drug: Placebo

Rifaximin-EIR 400 mg BID for 30 days

EXPERIMENTAL

1 x rifaximin delayed release 400 mg tablet + 1 x placebo tablet twice a day (total daily dose of rifaximin: 800 mg) for 30 days

Drug: Rifaximin delayed release 400 mg tablet; Drug: Placebo

Rifaximin-EIR 400 mg BID for 10 days

EXPERIMENTAL

1 x rifaximin delayed release 400 mg tablet + 1 x placebo tablet twice a day (total daily dose of rifaximin: 800 mg) for 10 days and 2 x placebo tablets twice a day for the following 20 days

Drug: Rifaximin delayed release 400 mg tablet; Drug: Placebo

Two placebo tablets BID for 30 days

PLACEBO COMPARATOR

2 x placebo tablets twice a day for 30 days

Drug: Placebo

Interventions

Rifaximin delayed release 400 mg tablet DRUG

Rifaximin delayed release

Rifaximin-EIR 400 mg BID for 10 days; Rifaximin-EIR 400 mg BID for 30 days; Rifaximin-EIR 800 mg BID for 10 days

Placebo DRUG

Placebo

Rifaximin-EIR 400 mg BID for 10 days; Rifaximin-EIR 400 mg BID for 30 days; Rifaximin-EIR 800 mg BID for 10 days; Two placebo tablets BID for 30 days

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 to 70 years at screening.
• Female participants are eligible if they are either of non-childbearing potential or 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.
• Moderate-to-severe papulopustular rosacea (a.k.a. subtype II, RII) at screening and confirmed at randomization. Moderate-to-severe rosacea is defined as the presence of 11 or more facial papules or pustules with or without plaques.
• Positivity of lactulose H2/CH4 breath test (L-BT) within the last 2-weeks before randomization.
• Patients accepting to provide and legally capable of providing free and informed consent to all procedures included in the protocol (including facial skin photography).

You may not qualify if:

• Granulomatous rosacea or rosacea fulminans.
• Erythematoteleangectatic, phymatous or ocular rosacea only. Patients with these subtypes associated with papulopustular rosacea can be enrolled.
• Circulating anti-helicobacter pylori IgM and/or IgG at screening (V1).
• Positivity at the faecal Clostridium Difficile toxin assay at screening (V1).
• History or family history of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or other conditions characterized by severe intestinal ulcers.
• History or family history of coeliac disease.
• Patients with intestinal obstruction or partial intestinal obstruction.
• Presence of diarrhoea associated with fever and/or blood in the stool.
• Health conditions requiring continuous or intermittent treatment with facial topical, inhaled or systemic steroids and/or biologic or non-biologic immunosuppressive or immunomodulatory agents (e.g. autoimmune diseases, etc.).
• 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.
• Facial skin conditions that can interfere with reliable assessment of rosacea throughout the study (e.g. keloids, hypertrophic scarring, recent facial surgery etc.)
• Any other significant health condition (e.g. cardiovascular, respiratory, renal, hepatic, neurologic, psychiatric, hematologic, oncologic, immune etc.) 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.).

Sponsors & Collaborators

• Alfasigma S.p.A.: lead

Study Sites (12)

Ospedali Riuniti di Ancona

Ancona, Italy

RECRUITING

Policlinico di Bari

Bari, Italy

RECRUITING

Policlinico Sant'Orsola Malpighi

Bologna, Italy

RECRUITING

Spedali Civili

Brescia, Italy

RECRUITING

Policlinico Vittorio Emanuele

Catania, Italy

RECRUITING

Ospedale Policlinico San Martino

Genova, Italy

RECRUITING

Ospedale della Misericordia

Grosseto, Italy

RECRUITING

Policlinico di Modena

Modena, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy

RECRUITING

Policlinico Universitario A. Gemelli

Roma, Italy

RECRUITING

Azienda Ospedaliera Santa Maria

Terni, Italy

RECRUITING

A.O.U. Città della Salute e della Scienza

Torino, Italy

RECRUITING

MeSH Terms

Conditions

Rosacea

Interventions

Tablets

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Alessandro Blè, MD

CONTACT

+39-051-6489619; alessandro.ble@alfasigma.com

Study Design

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

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 6, 2019
• Study Start: June 22, 2018
• Primary Completion: April 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

IT (12)