NCT04855188已完成不适用
A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 Versus YVOIRE Volume Plus in Nasolabial Folds Injection
LG Chem1 个研究点 分布在 1 个国家目标入组 394 人开始时间: 2021年7月1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
- 394
- 试验地点
- 1
- 主要终点
- WSRS responder rate
研究概览
简要总结
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection
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
- •3 (moderate) or 4 (severe) on the 5-graded WSRS
- •who sign the written informed consent form
排除标准
- •who have received permanent facial implants
- •who have received semi-permanent fillers
- •who have undergone temporary dermal filler treatment within 12 months
- •who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months
- •who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein
结局指标
主要结局
WSRS responder rate
时间窗: 24 weeks after the last injection
the proportion of subjects with ≥ 1 grade improvement on the wrinkle severity rating scale (WSRS) score
次要结局
未报告次要终点
研究者
研究点 (1)
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