NCT02028286已完成1 期
A Phase 1, Open Label, Multiple Center Study to Evaluate the Pharmacokinetics of Once-Daily CLS001 Topical Gel Under Maximal Use Conditions Administered for 21 Days in Subjects With Papulopustular Rosacea
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5
研究概览
简要总结
The purpose of this study is to characterize the pharmacokinetics of once daily topical gel and confirm that steady state conditions are reached under maximal use conditions following 3 weeks of daily applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A diagnosis of papulopustular rosacea
- •Grade 3 or 4 on the 5-point Investigator Global Assessment scale
- •Presence of telangiectasia
排除标准
- •steroid rosacea or subtype 3 (phymatous rosacea)
- •clinically significant abnormal findings that would interfere with study objective or risk to safety for the subject.
- •nodular rosacea (lesions greater than 5mm with more than 2 modules)
研究组 & 干预措施
CLS001
Experimental
CLS001
干预措施: CLS001 (Drug)
结局指标
主要结局
Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5
时间窗: 24 days
Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5.
次要结局
- incidence of adverse events(24 days)
研究者
研究点 (2)
Loading locations...
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