A Multicenter Randomized, Evaluator-Blinded, "No Treatment" Controlled Study to Evaluate the Effectiveness and Safety of Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Total Facial Volume Scale(FVS) improvement rate at Week 24
研究概览
简要总结
To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.
详细描述
This is a multicenter, randomized, evaluator-blinded, "no-treatment" controlled study conducted in normal, healthy subjects. This study is anticipated to enroll approximately 236 male and/or female subjects between the ages of 20 to 75 years, inclusive, who desire volume augmentation to correct deficit in their mid-face volume.
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
- 20 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 20 to 75 years of age
- •Subjects who desire volume augmentation to correct deficit in the mid-face volume that is rated as Grade 3, 4, or 5 on the Facial Volume Scale
排除标准
- •Subjects who have received anti coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs.
- •Subjects who have undergone facial plastic surgery in the face area below the level of the lower orbital rim, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or are planning to undergo any of these procedures at any time during the clinical investigation.
研究组 & 干预措施
Investigational medical device
Neuramis® Volume Lidocaine
干预措施: experimental (Device)
Comparator device
No-treatment
干预措施: comparator (Drug)
结局指标
主要结局
Total Facial Volume Scale(FVS) improvement rate at Week 24
时间窗: Week 24
Facial Volume Scale score ranges from 0-5 with higher score indicating increasing severity of mid-face volume deficit / Proportion of subjects with Facial Volume Scale(FVS) showing ≥1-point improvement (Facial Volume Scale decrease ≥1) at Week 24 compared to Baseline
次要结局
- 6-point Facial Volume Scale(FVS) improvement rate at Weeks 4, 12, 36, and 52(Weeks 4, 12, 36, and 52)
- Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52(Weeks 4, 12, 24, 36, and 52)
- Global Aesthetic Improvement Scale(GAIS) improvement rate at Weeks 4, 12, 24, 36, and 52(Weeks 4, 12, 24, 36, and 52)