NCT04437745已完成不适用
A Multicenter, Randomized, Rater-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
LG Chem1 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2020年11月25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
- 238
- 试验地点
- 1
- 主要终点
- Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate
研究概览
简要总结
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults 18 to 65 years of age (inclusive)
- •3 (moderate) or 4 (severe) on MFVDA-SRS
- •sign the written informed consent form
排除标准
- •have streptococcal disease or bleeding disorder
- •have an active or infective skin disease, scars, or tumor on mid-face
- •have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
- •have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment
- •have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months
- •have a medical history of hypertrophic cicatrix or keloid
- •have radiation therapy experience on mid-face
- •have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine, hyaluronic acid products, or Streptococcal protein
结局指标
主要结局
Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate
时间窗: 26 weeks from baseline
the proportion of subjects with ≥1-grade reduction on the MFVDA-SRS score (The MFVDA-SRS score ranges from 1-4 with higher score indicating increasing severity of mid-face volume deficit.)
次要结局
未报告次要终点
研究者
研究点 (1)
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