NCT03133325已完成不适用
A Randomized, Split Arm Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine
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
- 12
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to evaluate the incidence, intensity, duration and onset of adverse events following injection of GP0045
研究概览
简要总结
This is a study to assess the safety of GP0045 compared to Restylane Lyft Lidocaine.
There is a 12-week follow-up period. AEs will be recorded throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study
- •Signed and dated informed consent to participate in the study, including photo consent
- •Men or non-pregnant, non-breast feeding women aged 18 years or older
排除标准
- •Known/previous allergy or hypersensitivity to any injectable HA gel
- •Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics
- •Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
- •Participation in any other clinical study within 30 days before treatment
研究组 & 干预措施
All subjects
Other
Treatment with both GP0045 and Restylane Lyft Lidocaine
干预措施: GP0045 (Device)
All subjects
Other
Treatment with both GP0045 and Restylane Lyft Lidocaine
干预措施: Restylane Lyft Lidocaine (Device)
结局指标
主要结局
The primary objective of the study is to evaluate the incidence, intensity, duration and onset of adverse events following injection of GP0045
时间窗: 12 weeks
Incidence, intensity, duration, and onset of adverse events collected and assessed by the Investigator 12 weeks post treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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