A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24.
研究概览
简要总结
A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.
详细描述
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Classic plus Versus Comparator for Temporary Correction of Nasolabial Folds.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 21 years or above age.
- •2 or 3 of the 5-point (0-4) NLFRS (Nasolabial Fold Rating Scale).
- •Agree to use proper contraception as guided in the protocol.
- •Signed for Informed Consent.
排除标准
- •have received permanent facial implants anywhere in the face or neck or planning during the investigation.
- •have undergone facial plastic surgery of the lower face and nasolabial region within 12 weeks
- •have undergone semi-permanent filler in lower face
- •have undergone temporary dermal filler treatment in the lower two-thirds of face within 12 months
- •Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower two-thirds of face
- •Have undergone mesotherapy or cosmetic procedures in face or neck within 6 months
- •have used any over-the-counter anti-wrinkle products or prescription anti-wrinkle medicines for the nasolabial folds within 28 days
结局指标
主要结局
Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24.
时间窗: 24 weeks from baseline
To evaluate the performance of YVOIRE Classic plus on Nasolabial fold 24 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Nasolabial Fold Rating Scale (NLFRS) from baseline to 24 weeks will be calculated.
Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24.
时间窗: 24 weeks from baseline
To evaluate the performance of YVOIRE Classic plus on Nasolabial Fold 24 weeks after treatment, the mean change from baseline to 24 weeks will be measured using 5-point Nasolabial Fold Rating Scale (NLFRS). NLFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Extreme).
次要结局
未报告次要终点