NCT03300466已完成不适用
A Randomized, Controlled, Evaluator-blinded, Split Face Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
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
- 20
- 试验地点
- 1
- 主要终点
- Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
研究概览
简要总结
This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds.
There is an 18 months follow up period.
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
- 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
- •Subjects with intent to undergo correction of both nasolabial folds
排除标准
- •Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (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 with an investigational product within 30 days before treatment
研究组 & 干预措施
GP0045
Experimental
Treatment with GP0045
干预措施: GP0045 (Device)
Comparator
Active Comparator
Treatment with active comparator
干预措施: Comparator (Device)
结局指标
主要结局
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
时间窗: 6 months
The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.
次要结局
- Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale(2 weeks, 3, 9, 12, 15 and 18 months)
研究者
研究点 (1)
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