A Prospective, Randomized, and Split-Face Study to Evaluate the Efficacy and Safety of Focused Ultrasound for Facial Skin Laxity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in facial skin laxity from baseline assessed by VISIA skin analysis system
研究概览
简要总结
The goal of this clinical trial is to learn if focused ultrasound can improve facial skin laxity in adults. The main questions this study aims to answer are:
- Does focused ultrasound treatment lead to clinically meaningful improvement in facial skin laxity compared with baseline assessments?
- What treatment-related adverse events occur following focused ultrasound treatment, and how frequently and severely do they occur? Researchers will also compare outcomes between the two sides of the face treated with different focused ultrasound hand-pieces within the same participants to explore potential differences in clinical response and safety using a randomized split-face design.
Participants will:
Receive a single session of focused ultrasound treatment applied to both sides of the face.
Undergo standardized clinical assessments, imaging evaluations, and patient-reported outcome measures at baseline and during follow-up visits.
Be monitored for treatment-related adverse events throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older
- •Male or female participants
- •Presence of mild to moderate facial skin laxity
- •Willingness to undergo focused ultrasound treatment of the face
- •Ability to understand the study procedures and provide written informed consent
- •Willingness to comply with study visits and follow-up assessments
排除标准
- •Pregnancy or breastfeeding
- •Severe systemic diseases, including but not limited to significant cardiac, hepatic, renal, or neurological disorders
- •Active skin infection, inflammation, or open wounds in the treatment area
- •History of facial cosmetic procedures (including laser treatment, injectable fillers, or energy-based devices) within the past 6 months
- •Presence of implanted electronic devices or metallic implants in the facial area
- •Known hypersensitivity or contraindications to focused ultrasound treatment
- •Any condition that, in the investigator's judgment, would make the participant unsuitable for study participation
研究组 & 干预措施
Focused Ultrasound with Dot Hand-piece
干预措施: Focused UltrasoundDot Hand-piece (FUS-D) (Device)
Focused Ultrasound With Micro-focused Hand-piece
干预措施: Focused Ultrasound Micro-focused Hand-piece (FUS-M) (Device)
结局指标
主要结局
Change in facial skin laxity from baseline assessed by VISIA skin analysis system
时间窗: Baseline to 6 months post-treatment
Facial skin laxity will be quantitatively assessed using the VISIA skin analysis system. Skin laxity-related parameters will be measured at baseline, immediately post-treatment, and at 1,3, and 6 months post-treatment. Higher values indicate greater skin laxity. The change from baseline at each follow-up time point will be analyzed.
Incidence and severity of treatment-related adverse events
时间窗: From treatment through 6 months post-treatment
Treatment-related adverse events will be recorded and evaluated throughout the study, including the type, frequency, and severity of adverse events following focused ultrasound treatment.
次要结局
- Facial skin laxity assessed by VISIA skin analysis system for bilateral facial sides(Baseline to 6 months post-treatment)
- Merz Aesthetic Scale (MAS) score assessed by independent blinded evaluators(Baseline to 6 months post-treatment)
- Global Aesthetic Improvement Scale (GAIS) score assessed by independent blinded evaluators(From treatment through 6 months post-treatment)
研究者
Huang Lvping
Chief Physician
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College