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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03864978
Recruitment Status : Unknown
Verified March 2019 by Alfasigma S.p.A..
Recruitment status was:  Recruiting
First Posted : March 6, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Alfasigma S.p.A.

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.


Condition or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: Rifaximin delayed release 400 mg tablet Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Rifaximin Delayed Release 400 mg Tablets in Patients With Moderate-to-severe Papulopustular Rosacea and Positive Lactulose Breath Test. A Multicenter Double-blind, Placebo-controlled Randomized Clinical Trial
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea
Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Rifaximin-EIR 800 mg BID for 10 days
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
Rifaximin delayed release

Drug: Placebo
Placebo

Experimental: Rifaximin-EIR 400 mg BID for 30 days
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
Rifaximin delayed release

Drug: Placebo
Placebo

Experimental: Rifaximin-EIR 400 mg BID for 10 days
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
Rifaximin delayed release

Drug: Placebo
Placebo

Placebo Comparator: Two placebo tablets BID for 30 days
2 x placebo tablets twice a day for 30 days
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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) [ Time Frame: 30 days ]
    changes in number of lesions

  2. Percent of participants showing treatment success (IGA score of 0 [clear] or 1 [almost clear]) at the end of treatment visit (day 30 ± 1) [ Time Frame: 30 days ]
    per cent changes in IGA score 0 and 1 patients


Secondary Outcome Measures :
  1. 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 [ Time Frame: 30 days ]
    changes respect to baseline

  2. Mean change from Baseline (day 1) in number of inflammatory lesions (papules, pustules or plaques) at day 10 ± 1 and day 60 ± 3 [ Time Frame: 10 and 60 days ]
    change respect to baseline

  3. Percent of participants showing treatment success (i.e. IGA score of 0 or 1) at day 10 ± 1 and day 60 ± 3 [ Time Frame: 10 and 60 days ]
    per cent changes in IGA score 0 and 1 patients

  4. Percent of participants with IGA score of 0 (clear) at day 10 ± 1, day 30 ± 1 and day 60 ± 3 [ Time Frame: 10, 30 and 60 days ]
    per cent changes in IGA score 0 patients

  5. 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 [ Time Frame: 10, 30 and 60 days ]
    change respect to baseline

  6. Mean change from Baseline (day 1) in facial non-transient erythema at day 10 ± 1, day 30 ± 1 and day 60 ± 3 (absent=0, mild=1, moderate=2, severe=3) [ Time Frame: 10, 30 and 60 days ]
    change respect to baseline

  7. Mean change from Baseline (day 1) in number of inflammatory lesions at day 10 ± 1 and day 60 ± 3 as provided by Canfield Image Analysis [ Time Frame: 10 and 60 days ]
    change respect to baseline

  8. Mean change from Baseline (day 1) in facial non-transient erythema score at day 10 ± 1, day 30 ± 1 and day 60 ± 3, based on global fractional area redness as provided by Canfield Image Analysis [ Time Frame: 10, 30 and 60 days ]
    change respect to baseline

  9. Mean change from Baseline in Basic Self-Esteem Scale at day 30 ± 1 and day 60 ± 3 [ Time Frame: 30 and 60 days ]
    change respect to previous evaluation

  10. Mean change from Baseline (day 1) in Dermatology Life Quality Index (10-item DLQI) at day 30 ± 1 and day 60 ± 3 [ Time Frame: 30 and 60 days ]
    change respect to baseline

  11. Mean difference in Treatment Satisfaction Questionnaire between study groups at day 30 ± 1 [ Time Frame: 30 days ]
    differences between treatment arms


Other Outcome Measures:
  1. Mean change from Baseline (day 1) in circulating inflammatory marker levels at 10 ± 1, day 30 ± 1 and day 60 ± 3 [ Time Frame: 10, 30 and 60 days ]
    change respect to baseline

  2. 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 [ Time Frame: 10, 30 and 60 days ]
    change respect to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key inclusion Criteria:

  1. Men and women aged 18 to 70 years at screening.
  2. 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.
  3. 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.
  4. Positivity of lactulose H2/CH4 breath test (L-BT) within the last 2-weeks before randomization.
  5. Patients accepting to provide and legally capable of providing free and informed consent to all procedures included in the protocol (including facial skin photography).

Key exclusion Criteria:

  1. Granulomatous rosacea or rosacea fulminans.
  2. Erythematoteleangectatic, phymatous or ocular rosacea only. Patients with these subtypes associated with papulopustular rosacea can be enrolled.
  3. Circulating anti-helicobacter pylori IgM and/or IgG at screening (V1).
  4. Positivity at the faecal Clostridium Difficile toxin assay at screening (V1).
  5. History or family history of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or other conditions characterized by severe intestinal ulcers.
  6. History or family history of coeliac disease.
  7. Patients with intestinal obstruction or partial intestinal obstruction.
  8. Presence of diarrhoea associated with fever and/or blood in the stool.
  9. 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.).
  10. Severe kidney impairment (i.e. estimated glomerular filtration rate <30 ml/min).
  11. Severe hepatic impairment (i.e. Child-Pugh B or C).
  12. Cancer or any cancer-related treatment within 5 years prior to screening (excluding non-melanoma skin-cancer).
  13. History of alcohol or drug abuse within a year prior to screening.
  14. Facial skin conditions that can interfere with reliable assessment of rosacea throughout the study (e.g. keloids, hypertrophic scarring, recent facial surgery etc.)
  15. 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.).
  16. History of hypersensitivity to rifaximin, rifamycin-derivatives, any of the rifaximin-EIR excipients, or any UV protection cream component.
  17. Treatment with biologic immunomodulatory and/or immunosuppressive drugs (e.g. anti-TNF drugs) within 6 months prior to randomization.
  18. Treatment with non-biologic immunomodulatory and/or immunosuppressive drugs (e.g. cyclosporine, methotrexate etc.) within 30 days prior to randomization.
  19. Treatment with warfarin within 14 days prior to randomization.
  20. Treatment with niacin within 30 days prior to randomization.
  21. Topical facial or systemic antibiotics within 30 days before randomization;
  22. Treatment with neomycin or other low-absorbable oral antibiotics (such as marketed rifaximin) within 90 days before randomization.
  23. Topical facial, inhaled or systemic corticosteroids within 30 days prior to randomization.
  24. Topical facial retinoids within 30 days before randomization.
  25. Systemic retinoids within 6 months before randomization.
  26. Any other topical or systemic treatment for rosacea within 30 days before randomization (including also laser and pulsed light, etc.).
  27. Pharmaceutical prebiotics and probiotics (functional food is allowed), within 30 days before randomization.
  28. Any experimental treatment within 6 months prior to randomization.
  29. Women who are pregnant, breast-feeding or planning a pregnancy during the trial period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864978


Contacts
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Contact: Alessandro Blè, MD +39-051-6489619 alessandro.ble@alfasigma.com

Locations
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Italy
Ospedali Riuniti di Ancona Recruiting
Ancona, Italy
Policlinico di Bari Recruiting
Bari, Italy
Policlinico Sant'Orsola Malpighi Recruiting
Bologna, Italy
Spedali Civili Recruiting
Brescia, Italy
Policlinico Vittorio Emanuele Recruiting
Catania, Italy
Ospedale Policlinico San Martino Recruiting
Genova, Italy
Ospedale della Misericordia Recruiting
Grosseto, Italy
Policlinico di Modena Recruiting
Modena, Italy
Azienda Ospedaliera Universitaria Federico II Recruiting
Napoli, Italy
Policlinico Universitario A. Gemelli Recruiting
Roma, Italy
Azienda Ospedaliera Santa Maria Recruiting
Terni, Italy
A.O.U. Città della Salute e della Scienza Recruiting
Torino, Italy
Sponsors and Collaborators
Alfasigma S.p.A.
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Responsible Party: Alfasigma S.p.A.
ClinicalTrials.gov Identifier: NCT03864978    
Other Study ID Numbers: REROS/001/17
2017-003722-33 ( EudraCT Number )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents