NCT01853722已完成2 期
A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to Unisol® Following Topical Periocular Administration in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change from baseline in periocular region bacterial load
研究概览
简要总结
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Have given a written, informed consent
- •Be willing and able to follow all instructions
- •A negative urine pregnancy test if female of childbearing potential
排除标准
- •Known sensitivities to study medication or its components
- •Any signs of an active infection
- •Use of disallowed products during the period indicated prior to the enrollment or during the study
- •Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
- •Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
研究组 & 干预措施
DCN01
Experimental
干预措施: DCN01 (Drug)
Unisol
Placebo Comparator
干预措施: Unisol (Drug)
结局指标
主要结局
Change from baseline in periocular region bacterial load
时间窗: Baseline to 10 min post dose
次要结局
- Proportion of periocular regions with a reduction from baseline in bacterial load.(Baseline to 10 min post dose)
研究者
研究点 (1)
Loading locations...
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