NCT03753152已完成不适用
A Multicenter Randomized, Evaluator-Blinded, Active Controlled Design Study to Evaluate the Safety and Effectiveness of Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds
Medy-Tox1 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2018年4月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- WSRS improvement rate at Week 24
研究概览
简要总结
This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.
详细描述
Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18 to 75 years of age.
- •Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS.
排除标准
- •Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications.
- •Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.
结局指标
主要结局
WSRS improvement rate at Week 24
时间窗: Week 24
WSRS improvement rate at Week 24
次要结局
- GAIS improvement rate on Week 4, 12, 24, 36, and 52(Week 4, 12, 24, 36, and 52)
- WSRS improvement rate on Week 4, 12, 36, and 52(Week 4, 12, 36, and 52)
- Change of WSRS from Week 4, 12, 24, 36, and 52(Week 4, 12, 24, 36, and 52)
研究者
研究点 (1)
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