NCT02230761已完成2 期
A Phase 2, Randomized, Double-masked, Placebo-controlled Study of XOPH5 Ointment for Reduction of Lower Lid Steatoblepharon
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
- 90
- 试验地点
- 1
- 主要终点
- Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported
研究概览
简要总结
This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat).
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
- 40 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
XOPH5 Ointment
Experimental
XOPH5 Ointment is the investigational drug to be studied.
干预措施: XOPH5 Ointment (Drug)
Placebo Ointment
Placebo Comparator
Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
干预措施: Placebo (Drug)
结局指标
主要结局
Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported
时间窗: 11 weeks
Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.
次要结局
未报告次要终点
研究者
研究点 (1)
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