NCT06216418招募中不适用
A Single Center, Prospective, Comparative, Randomized, Double-blinded(Subject, Evaluator), Non-inferiority, Pivotal Clinical Study to Evaluate the Efficacy and Safety of the Polydioxanone Suture 'BRFS-18G-S100WH' Compared to 'MINT Lift FINE+' for Correction of the Nasolabial Folds
Hugel1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年2月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Improvement rate (%) at 12 weeks after the procedure compared to baseline.
研究概览
简要总结
Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds.
详细描述
This clinical trial was conducted on patients who wanted to improve both nasolabial folds through facial tissue lifting using facial tissue fixing material 'BRFS-18G-S100WH' made of polydioxanone (PDO). Compared to 'MINT Lift FINE+', we want to confirm whether it has a non-inferior temporary wrinkle improvement effect and can be safely applied to the human body.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 19 years of age
- •Those who wish to temporarily improve nasolabial folds on both sides of the face and have a score of 3 (Moderate) or 4 (Severe) on the WSRS (Wrinkle Severity Rating Scale)
- •Those who voluntarily decided to participate in this clinical trial and agreed to the subject description and consent form in writing
排除标准
- •A person who has undergone a procedure using filler or facial tissue fixation thread on the facial area.
- •Those who are pregnant or lactating
结局指标
主要结局
Improvement rate (%) at 12 weeks after the procedure compared to baseline.
时间窗: Baseline to week 12
Improvement rate (%) at 12 weeks after the procedure compared to baseline by an independent evaluator.
次要结局
- WSRS evaluation by an independent evaluator(Baseline to week 4, 8, 24)
- WSRS evaluation by tester(Baseline to week 4, 8, 24)
- Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline.(Baseline to week 4, 8, 12, 24)
研究者
研究点 (1)
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