Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test
- Conditions
- Papulopustular Rosacea
- Interventions
- Drug: Placebo
- Registration Number
- NCT03864978
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 236
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rifaximin-EIR 800 mg BID for 10 days Rifaximin delayed release 400 mg tablet 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 Rifaximin-EIR 400 mg BID for 30 days Rifaximin delayed release 400 mg tablet 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 Rifaximin-EIR 400 mg BID for 10 days Rifaximin delayed release 400 mg tablet 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 Two placebo tablets BID for 30 days Placebo 2 x placebo tablets twice a day for 30 days Rifaximin-EIR 800 mg BID for 10 days Placebo 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 Rifaximin-EIR 400 mg BID for 30 days Placebo 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 Rifaximin-EIR 400 mg BID for 10 days Placebo 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
- Primary Outcome Measures
Name Time Method 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) 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) 30 days per cent changes in IGA score 0 and 1 patients
- Secondary Outcome Measures
Name Time Method 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 changes respect to baseline
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 change respect to baseline
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 10 and 60 days change respect to baseline
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 10, 30 and 60 days change respect to baseline
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 per cent changes in IGA score 0 and 1 patients
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 per cent changes in IGA score 0 patients
Mean difference in Treatment Satisfaction Questionnaire between study groups at day 30 ± 1 30 days differences between treatment arms
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 change respect to baseline
Mean change from Baseline (day 1) in Dermatology Life Quality Index (10-item DLQI) at day 30 ± 1 and day 60 ± 3 30 and 60 days change respect to baseline
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) 10, 30 and 60 days change respect to baseline
Mean change from Baseline in Basic Self-Esteem Scale at day 30 ± 1 and day 60 ± 3 30 and 60 days change respect to previous evaluation
Trial Locations
- Locations (12)
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Azienda Ospedaliera Santa Maria
🇮🇹Terni, Italy
A.O.U. Città della Salute e della Scienza
🇮🇹Torino, Italy
Policlinico di Bari
🇮🇹Bari, Italy
Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
Spedali Civili
🇮🇹Brescia, Italy
Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Ospedale della Misericordia
🇮🇹Grosseto, Italy
Policlinico di Modena
🇮🇹Modena, Italy
Policlinico Universitario A. Gemelli
🇮🇹Roma, Italy