Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Investigator Assessment of Improvement at 12 weeks post-treatment
研究概览
简要总结
Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up visits.
详细描述
Before Treatment:
The subject's eligibility (inclusion/exclusion criteria) will be assessed, and all subjects will check the FACE-Q Appraisal of Neck scale score
Treatment:
The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200~260 lines of 3.0 and 4.5 probe respectively on the subject's neck.
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
- None
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.
- •Subject in good health
- •Subjects who desire improvement in neck skin
排除标准
- •Presence of an active systemic infectious disease
- •general disease or skin disorder in the area to be treated
- •Pregnant or lactating subjects
- •Previous episode of facial or neck surgery for wrinkle correction
- •Subjects who have aesthetic addiction, drug abuse, alcohol abuse
- •Subjects who were treated Botox or Filler at the neck area
- •Subjects who had Auto-Immune disease
研究组 & 干预措施
Ultherapy™ System
Ultherapy™ System
干预措施: Ultherapy™ System (Device)
结局指标
主要结局
Investigator Assessment of Improvement at 12 weeks post-treatment
时间窗: 12 weeks post-treatment
Investigator complete Global Aesthetic Improvement Scale at 12 weeks post-treatment by comparing subject's photographs
次要结局
- 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)