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
试验速览
- 阶段
- 2 期
- 入组人数
- 236
- 试验地点
- 12
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Rifaximin delayed release 400 mg tablet (Drug)
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
干预措施: Placebo (Drug)
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
干预措施: Rifaximin delayed release 400 mg tablet (Drug)
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
干预措施: Placebo (Drug)
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
干预措施: Rifaximin delayed release 400 mg tablet (Drug)
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
干预措施: Placebo (Drug)
Two placebo tablets BID for 30 days
2 x placebo tablets twice a day for 30 days
干预措施: Placebo (Drug)
结局指标
主要结局
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)
时间窗: 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)
时间窗: 30 days
per cent changes in IGA score 0 and 1 patients
次要结局
- 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)
- 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)
- 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)
- 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 difference in Treatment Satisfaction Questionnaire between study groups at day 30 ± 1(30 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)
- 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)
- 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)
- Mean change from Baseline in Basic Self-Esteem Scale at day 30 ± 1 and day 60 ± 3(30 and 60 days)