NCT01693055已完成不适用
Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid,Phase 4.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- The distance from the inferior orbital rim to the skin
研究概览
简要总结
Study title
- Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design
- single arm and Investigator Initiative pilot study
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
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age >20 years, Age < 50 years
- •people who want to improve baggy eyelid
- •Information consent obtained
排除标准
- •previous lower eyelid surgical history
- •scar on lower eyelid after trauma
- •bleeding tendency
- •aesthetic addiction, drug abuse, alcohol abuse
结局指标
主要结局
The distance from the inferior orbital rim to the skin
时间窗: Change from Screening in distance at 12weeks after Ulthera treatment
Difference between the distance ( from the inferior orbital rim to the skin) measured by orbital CT at Screening and 12weeks after UltheraTM treatment
次要结局
- Subject Satisfaction for baggy lower eyelid(Change from Screening in satisfaction at 4 weeks and 12weeks)
- The distance from the most protrusive baggy eyelid to the orbital septum(Change from Screening in distance at 12weeks after UltheraTM treatment)
- Improvement of baggy lower eyelid(Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment)
研究者
Chan-Yeong Heo
Assistant professor
Seoul National University Hospital
研究点 (2)
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