Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting, a Prospective, Multi-center, Evaluator Blinded, Randomized, Non-treatment Controlled, and Superiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CLASSYS Inc.
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- Global Aestetic Improvement Scale(GAIS)
研究概览
简要总结
The goal of this clinical trial is to assess the safety and efficacy of the high-intensity focused ultrasound (HIFU) device, ULTRAFORMER MPT (UF4-M400), developed by CLASSYS Inc., for eyebrow lifting. This study is a prospective, multicenter, evaluator-blinded, randomized, non-treatment-controlled, superiority clinical trial.
The main questions the study seeks to answer are:
Does the ULTRAFORMER MPT device effectively lift eyebrows? Is the safety profile of the ULTRAFORMER MPT device acceptable? Researchers will compare the investigational device to a non-treatment control group to determine whether the HIFU device demonstrates superiority in eyebrow lifting outcomes.
Participant Details:
Participants will receive a single treatment session using the investigational device or be assigned to the non-treatment control group.
Follow-up will occur over 3 months to evaluate the effectiveness and safety of the treatment.
Outcomes:
Primary Outcome: Eyebrow lifting improvement, assessed through standardized photographic evaluation and other aesthetic measurement tools.
Secondary Outcomes: Participant satisfaction using the Global Aesthetic Improvement Scale (GAIS) and pain assessment using a Visual Analog Scale (VAS).
Safety Measures: Monitoring for adverse events (AEs) and serious adverse events (SAEs) throughout the study period.
This trial aims to provide robust evidence supporting the use of the ULTRAFORMER MPT for non-invasive eyebrow lifting.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 20 to 65 years old at the time of consent.
- •Condition: Forehead skin laxity with Forehead Lines Grading Scale score of 1-
- •Consent: Ability to understand trial details, voluntarily participate, and comply with treatment and follow-up.
排除标准
- •Skin Conditions: Hyperpigmentation, tattoos, scars, active skin diseases, or other conditions (e.g., eczema, psoriasis, vitiligo) in the treatment area that may affect efficacy or increase risk.
- •Medical Devices or Implants: Presence of metal implants or embedded electronic devices in the treatment area.
- •Health Conditions: Severe dysfunction of vital organs (e.g., heart, liver, kidneys), autoimmune diseases, or uncontrolled diabetes.
- •Medications: Recent use of anti-thrombotic agents, NSAIDs, or other drugs affecting coagulation within one week before screening.
- •Prior Treatments: Use of fillers (e.g., hyaluronic acid, collagen) or cosmetic procedures (e.g., laser therapy, botulinum toxin) in the treatment area within the specified timeframes.
- •Pregnancy: Women who are pregnant, nursing, or not using birth control during the trial.
研究组 & 干预措施
ULTRAFOMER MPT
This arm receives the high-intensity focused ultrasound (HIFU) treatment, which is the primary intervention being evaluated for efficacy and safety in eyebrow lifting.
干预措施: HIFU treatment with ULTRAFOMER MPT (Device)
No Treatment
This arm does not receive any treatment, serving as a comparison group to evaluate the efficacy of the investigational device.
结局指标
主要结局
Global Aestetic Improvement Scale(GAIS)
时间窗: 3 months after treatment
Improvement was defined as GAIS score≤3 Min 1 Max 5 1. Very much improved 2. Much improved 3. Improved 4. No Change 5. Worse
次要结局
未报告次要终点