NCT03160716已完成不适用
A Multicenter, Open-Label, Prospective Study of Cannula Injection of Restylane Lyft With Lidocaine for Cheek Augmentation and the Correction of Age Related Midface Contour Deficiencies
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
- 60
- 试验地点
- 4
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events [Safety]
研究概览
简要总结
This is a multi-center, open-label, single-arm study to evaluate an injection tool with Restylane Lyft with Lidocaine for cheek augmentation and correction of age related midface contour deficiencies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Primary Inclusion Criteria:
- •Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
- •Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
- •Mild to Substantial Midface Volume Loss
排除标准
- •Allergy or hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins
- •Allergy or hypersensitivity to lidocaine or other amide-type anaesthetics, or topical anaesthetics or nerve blocking agents
- •Undergone prior surgery to midface
研究组 & 干预措施
Treatment
Other
干预措施: Restylane Lyft with Lidocaine (Device)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events [Safety]
时间窗: 16 weeks
To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula.
次要结局
- Subject Satisfaction(8 weeks)
- Number of Participants That Responded to Treatment(16 weeks)
- Number of Participants With Aesthetic Improvement(16 weeks)
研究者
研究点 (4)
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