NCT01174030已完成2 期
A 4-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled, Multicenter Study Investigating the Efficacy and Safety of CD07805/47 Gel 0.5% Applied Topically Once Daily (QD), and CD07805/47 Gel 0.18% Applied Topically Once Daily (QD) or Twice Daily (BID), in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 269
- 试验地点
- 20
- 主要终点
- Composite Success
研究概览
简要总结
The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.
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
- Double (Participant, Investigator)
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
- •Male or female, who is at least 18 years of age or older.
- •A clinical diagnosis of rosacea.
- •A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day
- •A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day
- •A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on Baseline/Day 1.
排除标准
- •Three (3) or more facial inflammatory lesions.
- •Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
- •Known allergies or sensitivities to any components of the study medications, including the active gel ingredient, brimonidine tartrate.
- •Intraocular pressure (IOP) measurement less than 10 mm Hg.
研究组 & 干预措施
CD07805/47 Gel 0.5% QD
Experimental
干预措施: CD07805/47 Gel (Drug)
CD07805/47 Gel 0.18% QD
Experimental
干预措施: CD07805/47 Gel (Drug)
CD07805/47 Gel 0.18% BID
Experimental
干预措施: CD07805/47 Gel (Drug)
Vehicle Gel QD
Placebo Comparator
干预措施: Vehicle Gel (Drug)
Vehicle Gel BID
Placebo Comparator
干预措施: Vehicle Gel (Drug)
结局指标
主要结局
Composite Success
时间窗: Day 29
Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
次要结局
- CEA Success(Day 29)
- PSA-5 Success(day 29)
研究者
研究点 (20)
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