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
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
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)
Loading locations...
相似试验
已完成
4 期
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne ScarsHealthy VolunteersNCT03127384Galderma R&D49
已完成
不适用
Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial FoldsNasolabial Folds in Chinese PopulationNCT02432742Galderma R&D100
已完成
不适用
Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial FoldsNasolabial FoldsNCT00797459Medicis Global Service Corporation60
已完成
不适用
Restylane Defyne in a Stepwise Treatment ApproachLower Face Folds and LinesNCT04520997Galderma R&D62
已完成
不适用
Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin ProfileChin AugmentationChin RetrusionNCT05777759Galderma R&D175