Papulopustular RosaceaPhase 2NCT03864978
Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test
A Phase 2 study testing Rifaximin delayed release 400 mg tablet in people with Papulopustular Rosacea, run by Alfasigma S.p.A. at 12 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Papulopustular Rosacea
- What is being tested?
- Rifaximin delayed release 400 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 12 sitesItaly
- Study dates
- 22 Jun 2018to Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 29Show fewer
- 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.).
- History of hypersensitivity to rifaximin, rifamycin-derivatives, any of the rifaximin-EIR excipients, or any UV protection cream component.
- Treatment with biologic immunomodulatory and/or immunosuppressive drugs (e.g. anti-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 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 (such as marketed rifaximin) 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.).
- Pharmaceutical prebiotics and probiotics (functional food is allowed), within 30 days before randomization.
- Any experimental treatment within 6 months prior to randomization.
- Women who are pregnant, breast-feeding or planning a pregnancy during the trial period.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites, 12 recruiting
- Recruiting
Ospedali Riuniti di Ancona
Ancona
- Recruiting
Policlinico di Bari
Bari
- Recruiting
Policlinico Sant'Orsola Malpighi
Bologna
- Recruiting
Spedali Civili
Brescia
- Recruiting
Policlinico Vittorio Emanuele
Catania
- Recruiting
Ospedale Policlinico San Martino
Genova
- Recruiting
Ospedale della Misericordia
Grosseto
- Recruiting
Policlinico di Modena
Modena
- Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples
- Recruiting
Policlinico Universitario A. Gemelli
Roma
- Recruiting
Azienda Ospedaliera Santa Maria
Terni
- Recruiting
A.O.U. Città della Salute e della Scienza
Torino
About this study
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
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
- Being tested
- Rifaximin delayed release 400 mg tablet, Placebo
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin delayed release 400 mg tabletDrug
Rifaximin delayed release
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
changes respect to baseline
Measured: 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
change respect to baseline
Measured: 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
per cent changes in IGA score 0 and 1 patients
Measured: 10 and 60 days
Percent of participants with IGA score of 0 (clear) at day 10 ± 1, day 30 ± 1 and day 60 ± 3
per cent changes in IGA score 0 patients
Measured: 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
change respect to baseline
Measured: 10, 30 and 60 days
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)
change respect to baseline
Measured: 10, 30 and 60 days
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
change respect to baseline
Measured: 10 and 60 days
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
change respect to baseline
Measured: 10, 30 and 60 days
Mean change from Baseline in Basic Self-Esteem Scale at day 30 ± 1 and day 60 ± 3
change respect to previous evaluation
Measured: 30 and 60 days
Mean change from Baseline (day 1) in Dermatology Life Quality Index (10-item DLQI) at day 30 ± 1 and day 60 ± 3
change respect to baseline
Measured: 30 and 60 days
Mean difference in Treatment Satisfaction Questionnaire between study groups at day 30 ± 1
differences between treatment arms
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start22 Jun 2018
- Primary completionApr 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papulopustular RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864978
- Sponsor's protocol ID
- REROS/001/17
- Other IDs
- 2017-003722-33, 2017
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03864978
- Acronym / sponsor ID
- REROS/001/17
- Conditions
- Papulopustular Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Alfasigma S.p.A.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rifaximin-EIR 800 mg BID for 10 days | Experimental | Drug: Rifaximin delayed release 400 mg tablet, Drug: Placebo2 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 |
| Rifaximin-EIR 400 mg BID for 30 days | Experimental | Drug: Rifaximin delayed release 400 mg tablet, Drug: Placebo1 x rifaximin delayed release 400 mg tablet + 1 x placebo tablet twice a day (total daily dose of rifaximin: 800 mg) for 30 days |
| Rifaximin-EIR 400 mg BID for 10 days | Experimental | Drug: Rifaximin delayed release 400 mg tablet, Drug: Placebo1 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 |
| Two placebo tablets BID for 30 days | Placebo comparator | Drug: Placebo2 x placebo tablets twice a day for 30 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximin delayed release 400 mg tabletRifaximin delayed release | Drug | Rifaximin-EIR 400 mg BID for 10 days, Rifaximin-EIR 400 mg BID for 30 days, Rifaximin-EIR 800 mg BID for 10 days |
| PlaceboPlacebo | Drug | 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 |
Primary outcome
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
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
11 secondary outcomes
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
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
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
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
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
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
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
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
Mean change from Baseline in Basic Self-Esteem Scale at day 30 ± 1 and day 60 ± 3
Time frame: 30 and 60 days
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
Mean difference in Treatment Satisfaction Questionnaire between study groups at day 30 ± 1
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
Related trials for Papulopustular Rosacea
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Rosacea Radiofrequency Microneedling
Rosacea, Papulopustular, Rosacea, Erythematotelangiectatic
RecruitingPhase 2
Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea
Papular-pustular Rosacea, Papulopustular Rosacea (PPR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifaximin delayed release 400 mg tablet in people with Papulopustular Rosacea, run by Alfasigma S.p.A. at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Blè, MD (+39-051-6489619, alessandro.ble@alfasigma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.