NCT03932045已完成不适用
A Randomized, Subject & Evaluator-blind, Matched Pairs, Prospective Study to Compare the Safety and Efficacy Between SYB Filler (SF-01) and Ellansé M in the Correction of Nasolabial Folds
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2018年10月8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
- 59
- 试验地点
- 1
- 主要终点
- Change From Baseline to 12months in Wrinkle Severity Rating Scale (WSRS) Score by independent evaluator assessed
研究概览
简要总结
The objective of this clinical trial is to verify the safety and efficacy of SYB Filler (SF-01) in the temporary improvement 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS)
- •Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study.
排除标准
- •Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening
- •Administered Vitamin E or non-steroidal anti-inflammatory drugs or Collagen within 1 week of the date of the screening, or who require these during the period of the study
- •History of bleeding disorder in past or present
- •Received deep-peeling, skin regeneration, plastic surgery (including botulinum toxin injection), wrinkle improvement or acne scar treatment in the facial area within 24 weeks of the date of the screening
- •Administered an hyaluronic acid filler within 24 weeks of the date of the screening
结局指标
主要结局
Change From Baseline to 12months in Wrinkle Severity Rating Scale (WSRS) Score by independent evaluator assessed
时间窗: 12months
The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.
次要结局
未报告次要终点
研究者
研究点 (1)
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