NCT02545608已完成不适用
A Randomised, Multi-centre, Evaluator-blinded, Split-hand, no Treatment-controlled Study to Evaluate the Safety and Efficacy of Restylane Vital for Skin Rejuvenation of the Dorsal Hands in Chinese Subjects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of using Restylane Vital for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will be done by a blinded evaluator.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Chinese origin
- •Subject willing and able to comply with the requirements of the study and agrees to adhere to the visit schedule and to be compliant to the study instructions
排除标准
- •Any previous non-permanent implant/filler in the hands
- •Any mesotherapy or resurfacing procedure in the hands within 6 months prior to baseline
- •Any previous hand surgery
- •Any fibrosis or scarring or deformities on the hands
- •Advanced photoaged/photodamaged skin
研究组 & 干预措施
Restylane Vital in both hands
Experimental
Open group used to develop a proper use of injection technique for Restylane Vital
干预措施: Restylane Vital (Device)
Restylane Vital and No treatment
Other
Split-hand design: Restylane Vital in one hand and initially no treatment in the other hand
干预措施: Restylane Vital (Device)
结局指标
主要结局
The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale.
时间窗: 12 weeks
Assessment of the severity of hand aging using a 5-point (ranging from 0-5) photo numeric rating scale (Hand Grading Scale), where higher scores mean a worse outcome.
次要结局
未报告次要终点
研究者
研究点 (2)
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