NCT02607683已完成2 期
A Phase 2b/3, Multicenter, Dose-ranging, Randomized, Double-masked, Placebo-controlled Study of XAF5 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
- 300
- 试验地点
- 6
- 主要终点
- LESS score (Clinician-Reported)
研究概览
简要总结
This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid steatoblepharon (undereye bags).
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
- Triple (Participant, 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
- •Moderate to severe, bilateral lower eyelid steatoblepharon
- •Must understand and provide informed consent
- •Healthy facial skin
排除标准
- •Pregnant or lactating women
- •Clinically significant eye disease
- •Best corrected visual acuity worse than 20/40 in either eye
- •History of eye surgery in past 6 months
- •History of lower eyelid surgery
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will apply Placebo Ointment to the lower eyelids once daily.
干预措施: Matching placebo (Drug)
结局指标
主要结局
LESS score (Clinician-Reported)
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (6)
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