NCT02780258已完成不适用
Restylane Silk for Photoaged Thinned Hands
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Change in photoaged thinning of the treatment area as measured by the 5 point hand grading scale
研究概览
简要总结
To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female volunteer
- •Aged from 40-70 years on the day of screening
- •No known medical conditions that may interfere with study participation
- •Moderate to very severe Photoaged thinning of the hands based on the 5-point hand grading scale
- •Willingness to not use any products on their hands for the duration of the study
- •Read, understand, and sign informed consent forms
- •Willingness to sign photography release form
- •Willing and able to comply with all follow-up requirements
- •Willingness to undergo Restylane Silk injections to one hand
排除标准
- •Any significant skin disease at treatment area
- •Any medical condition which could interfere with the treatment
- •Inability or unwillingness to follow the treatment schedule
- •Inability or unwillingness to sign the informed consent
- •History of poor wound healing
- •History of keloid formation
- •History of HIV, hepatitis, immuno-compromised
- •Pregnant or lactating
- •Previous use of deep chemical peels on the treatment area
- •Previous injections of Restylane Silk to the hands
- •Known hypersensitivity to Restylane Silk or any of its ingredients
- •Previous laser or light based treatments to the treatment area 6 months prior to the screening visit
研究组 & 干预措施
Control Hand
No Intervention
The dorsal aspect of the hand that is not treated will be used for baseline comparison.
Restylane Silk Treated Hand
Experimental
The dorsal aspect of one hand will be injected with Restylane Silk.
干预措施: Restylane Silk (Device)
结局指标
主要结局
Change in photoaged thinning of the treatment area as measured by the 5 point hand grading scale
时间窗: Baseline, 1month, 3months, 6 months
次要结局
未报告次要终点
研究者
David J. Goldberg, MD
David J. Goldberg, MD, JD
Skin Laser & Surgery Specialists
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