A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate Performance and Safety of YVOIRE Volume Plus Versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Responder rate of YVOIRE volume plus
研究概览
简要总结
A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume
详细描述
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of 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 (Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female aged between 21 to 75 years (inclusive)
- •2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale)
- •Desire cheek augmentation to correct volume deficit in the midface.
- •Agree to use contraception
- •Sign Informed Consent Form
排除标准
- •have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area
- •have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening
- •have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
- •have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein
- •have history of bleeding disorder
- •have a tendency to develop hypertrophic scarring or keloid
结局指标
主要结局
Responder rate of YVOIRE volume plus
时间窗: 24 weeks from baseline
To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment
Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine
时间窗: 24 weeks from baseline
To demonstrate non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine in the improvement of mid face volume by comparing the mean change from Baseline in the Mid Face Volume Loss Rating Scale (MFVLRS) at 24 weeks after the final treatment
次要结局
- Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS)(4, 8, 12, 24, 52 weeks from baseline)
- The mean scores of the GAIS(4, 8, 12, 24, 52 weeks from baseline)
- Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS)(4, 8, 12, 52 weeks from baseline)
- Responder rate of YVOIRE volume plus(4, 8, 12, 52 weeks from baseline)
- Mean change in mid-face volume(24 weeks from baseline)