Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand
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
- Investigator's evaluation of 5-point Hand grading scale
研究概览
简要总结
Enrolled subjects will receive Ultherapy™ System treatment on the back of their both hands. Follow-up visits will occur at 90 days post-treatment. Study photos will be obtained pre-treatment and at 90 days post-treatment
详细描述
Before Treatment:
The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the 5-point Hand Grading Scale wil be evaluated by the Investigator in charge of assessment.
Treatment:
The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 20 lines of 1.5 and 3.0 probe respectively to the back of the left and right hand .
Post-Treatment:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 30 to 65 years.
- •Score of 1 to 3 on The 5-point Hand Grading Scale
- •Subjects who understand the study contents and signed the informed consent
排除标准
- •Presence of an active systemic infectious disease
- •Significant scarring in the hand to be treated
- •Previous episode of surgery in the hand to be treated
- •Subjects who have aesthetic addiction, drug abuse, alcohol abuse
结局指标
主要结局
Investigator's evaluation of 5-point Hand grading scale
时间窗: 12 weeks post-treatment
2 assessors will be evaluate 5-point Hand grading scale from baseline and 12weeks post treatment
次要结局
- Investigator Assessment of Improvement at 12 weeks post-treatment(12 weeks post-treatment)
- Subject Assessment of Improvement at 12 weeks post-treatment(12 weeks post-treatment)
- Subjects' Assessment of Pain during treatment(Subjects were assessed for the duration of study treatment)