NCT01693055已完成不适用
Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid,Phase 4.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 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
研究组 & 干预措施
UltheraTM
Experimental
UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe
干预措施: UltheraTM 100 shots (Device)
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 (1)
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