NCT02650921已完成不适用
A Randomized, Evaluator Blinded, Split-hand Study to Evaluate the Effectiveness and Safety of Restylane Lyft With Lidocaine Compared to no Treatment for Injection in the Dorsal Hand to Correct Volume Deficit
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 92
- 试验地点
- 7
- 主要终点
- Responder Rate Using Validated Hand Grading Scale
研究概览
简要总结
This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the dorsal hand to correct volume deficits.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects willing to comply with the requirements of the study and providing a signed written informed consent including release of copyright of hand images.
- •Males or females, 22 years of age or older
- •Willing and able to perform hand functionality tests .
排除标准
- •History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
- •History of allergy or hypersensitivity to lidocaine or other amide type anesthetics.
- •Previous hand surgery including sclerotherapy, or history of hand trauma.
- •Advanced photo aged/ photo damaged skin or skin condition with very crinkled or fragile skin on the dorsal hands.
结局指标
主要结局
Responder Rate Using Validated Hand Grading Scale
时间窗: 12 Weeks
A responder is defined as a hand with at least one improvement from baseline.
次要结局
- Question 12 From Subject Satisfaction Questionnaire(Week 12)
- Question 4 From Subject Satisfaction Questionnaire(Week 12)
- Question 3 From Subject Satisfaction Questionnaire(Week 12)
- Question 8 From Subject Satisfaction Questionnaire(Week 12)
- Question 11 From Subject Satisfaction Questionnaire(Week 12)
- Responder Rate Using Validated Hand Grading Scale(24 weeks)
- Improvement in Hand as Evaluated by IPR(24 weeks)
- GAIS by Treating Investigator(24 weeks)
- Evaluate GAIS by Subjects(20 weeks)
- Evaluate GAIS by Subject(24 weeks)
- Question 2 From Subject Satisfaction Questionnaire(Week 12)
- Question 7 From Subject Satisfaction Questionnaire(Week 12)
- Question 9 From Subject Satisfaction Questionnaire(Week 12)
- Question 10 From Subject Satisfaction Questionnaire(Week 12)
- Question 6 From Subject Satisfaction Questionnaire(Week 12)
- Question 1 From Subject Satisfaction Questionnaire(Week 12)
- Question 5 From Subject Satisfaction Questionnaire(Week 12)
- Question 13 From Subject Satisfaction Questionnaire(Week 12)
研究者
研究点 (7)
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