NCT06449911Unknown不适用
Efficacy and Safety of High Intense Focused Ultrasound for Treating Middle and Lower Face and Submental Region Laxity
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity
研究概览
简要总结
This is a prospective study of 20 Chinese patients with lower facial laxity treated by High Intense focused ultrasound (HIFU). Response will be assessed via paired comparison of pretreatment and posttreatment photographs by two independent dermatologists, grading on a 5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity. Quantitative analysis of submental lifting will also be performed. Patient's level of "sagging" and "volume loss", satisfaction and tolerance will be documented.
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •healthy male or female, aged 30-60 years, seeking improved jawline definition, and/or reduction of submental skin laxity and were willing and able to provide informed consent.
排除标准
- •Pregnancy or lactation, severe sun damage, excessive skin laxity on the lower face and neck, keloid scarring or open wounds in the treatment areas, severe or cystic facial acne, history of cosmetic treatments in the area to be treated (skin tightening procedure within the past year; injectable filler or botox within the past 6 months; ablative or nonablative resurfacing/rejuvenating laser treatment or light treatment within the past 6 months; dermabrasion or deep facial peels within the past 6 months), isotretinoin treatment within the past 6 months, and inability to understand the treatment protocol or to give informed consent.
结局指标
主要结局
5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity
时间窗: 6 months after HIFU treatment
0-worse, 1-0%-25% poor response, 2-25%-50% fair response, 3-50%-75% good response, 4-75%-100%-excellent response.
次要结局
未报告次要终点
研究者
研究点 (1)
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