Sonography-Guided Volumetric Rejuvenation on Dorsal Hands: A Split-Hand Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Aesthetic improvement
研究概览
简要总结
The goal of this randomized controlled study is to guide volumetric rejuvenation on dorsal hands with the maximal aesthetic appearance. The main questions it aims to answer are:
- Which fatty layer(s) is/are the most suitable for filler injection?
- Is it feasible to make precise filler injections with sonography guidance? Participants will receive sonography-guided injection on the one hand and another with blinded injection.
详细描述
In our previous study, volumetric fat loss was noted in the 3 fatty laminae of dorsal hands during aging; the dorsal intermediate lamina (DIL) showed the greatest progressive fat loss after the age of 30. Volumetric rejuvenation of the 3 laminae may result in the most aesthetic appearance, especially in women. It is necessary to develop precise rejuvenation therapies according to the aging process of the dorsum of the hands that will yield the most aesthetic appearance.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of aging changes on the dorsal hands
- •Aged ≥18 years
排除标准
- •History of severe hand dermatitis
- •History of rheumatic arthritis
- •History of major hand trauma
- •History of limb edema
- •History of recent significant weight changes
- •History of previous filler injection to the dorsal hands
- •History of intravenous catheter insertion and hemodialysis via the forearms or hands
研究组 & 干预措施
Sonography-guided hand
One hand of the participant will be treated with sonography-guided filler injection in random
干预措施: Volumetric rejuvenation (Procedure)
Blinded injected hand
One hand of the participant will be treated with filler injection by physician's experience without sonography-guidance in random
结局指标
主要结局
Aesthetic improvement
时间窗: Day 0, 30, 180 follow up
5-point global aesthetic improvement scales scoring (Min:1; Max:5)
次要结局
- Thickness of the fatty laer(Day 0, 30, 180 follow up)
研究者
Yi-Teng Hung
Consultant Fellow
Chang Gung Memorial Hospital