NCT02703948已完成不适用
Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation
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
- 60
- 试验地点
- 4
- 主要终点
- Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine
研究概览
简要总结
This is a multi-center, open-label, single-arm study to assess the safety of an injection technique with Restylane Silk in lip augmentation and correction of perioral rhytids .
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
- •Subjects willing to comply with the requirements of the study and providing written informed consent including release of copyright of photography images.
- •Males or females, 22 years of age or older
- •Subjects seeking augmentation therapy for the lips.
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, other amide type anesthetics, or topical anesthetics or nerve blocking agents
- •Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.
结局指标
主要结局
Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (4)
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