Rifaximin Treatment of Papulopustular Rosacea: Double- Blinded, Placebo-Controlled, Crossover Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Investigator's Global Assessment (IGA) Score of Rosacea Symptoms
研究概览
简要总结
The purpose of this study is to determine the effects of rifaximin on skin symptoms in patients with rosacea by double-blinded, placebo-controlled, crossover study.
详细描述
100 patients will be randomized into two groups.
Group A will receive one rifaximin 550 mg tablet three times a day (1650 mg/day) for 14 days, and after a 4-week washout period, receive one placebo tablet three times a day for 14 days.
Group B will receive placebo first, and then rifaximin with the same dosage schedule to Group A.
Assessments will be performed before application and 4 weeks after the last dosage, for both of rifaximin and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •> 18 years of age with rosacea defined as:
- •3-40 papules/pustules and < 2 nodules,
- •A score of 2-4 on the Investigator Global Assessment
排除标准
- •Untreated pancreatic insufficiency
- •Crohn's disease
- •Ulcerative colitis
- •Active celiac disease by clinical history
- •End stage renal failure
- •Less than 18 years old
- •Pregnancy or positive pregnancy test
- •Rosacea subtype 1 (no papules )
- •Topical or oral antibiotics within 4 weeks
- •Acne treatments within 4 weeks prior to randomization
- •Systemic retinoids within 90 days
- •Topical or systemic corticosteroids 4 weeks prior to randomization
研究组 & 干预措施
Rifaximin
rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days
干预措施: Rifaximin (XIFAXAN) (Drug)
sugar pill
Placebo 1 tablet three times a day for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Investigator's Global Assessment (IGA) Score of Rosacea Symptoms
时间窗: 14 days
A response to treatment is defined as the achievement of an IGA score of '0 or 1' at endpoint for moderate to severe patients and achievement of an IGA score of '0' at endpoint for mild patients.
次要结局
- Achieving an IGA score of 0.(14 days)