Clinical Study of Neuramis® Volume Lidocaine to Evaluate the Efficacy and Safety for Temporary Restoring the Mid-face Volume
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of Neuramis® Volume Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume restoration in mid-facial region. After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.
详细描述
This is a multi-centered, randomized, double-blind, split-face clinical study on investigational device. The subjects in this clinical trial receive application of the investigational device on the right and left side of the mid-facial region (Neuramis® Volume Lidocaine or Juvederm® Voluma® with Lidocaine). After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject aged between 35 and
- •Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level
排除标准
- •1. Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs
- •2. Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.
- •3. Those who has thin skin in the mid-facial area
- •4. Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics
- •\ Inclusion Criteria:
- •1. Participated in the pivotal study and completed the end of study visit
- •2. Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study
- •Exclusion Criteria
- •1. Those who have following procedual history between completion of the pivotal study and entry of extension study
- •- facial plastic surgery, tissue grafting or tissue augmentation using implant, thread lifting
- •2. Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment
结局指标
主要结局
Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)
时间窗: 104 weeks
Primary outcome for extension study
次要结局
- The changes in overall Mid-Face Volume Deficit Scale(MFVDS) at each visit(104 weeks)
- Ratio of subjects defined as improved by blinded investigators and the subjects according to the Global Aesthetic Improvement Scale (GAIS)(104 weeks)