NCT03170050已完成3 期
A Multicenter, Active-controlled, Randomized, Evaluator and Subject Blinded, Split-face, Comparative, Non-inferiority and Confirmatory Clinical Study of the Efficacy and Safety Between YYD701-2 and Restylane Perlane Lidocaine for Temporary Correction of Moderate to Severe Nasolabial Folds
Yooyoung Pharmaceutical Co., Ltd.2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2017年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.
研究概览
简要总结
A multicenter, active-controlled, randomized, evaluator and subject blinded, split-face, comparative, non-inferiority, Medical device Clinical trial.
This study is randomized, evaluator and subject blinded, split-face medical device Clinical trial. The Subjects are injected investigational device(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female aged between 30 and 75 years, inclusive
- •Subjects who want improvement of nasolabial folds that are rated as grade 3 or 4 on Wrinkle severity rating scale(WSRS)
- •Subjects who have visually symmetrical bilateral nasolabial folds
- •Subjects who consent to discontinue all dermatological treatment or cure including wrinkle correction in and around infraorbital region during this trial
- •Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form
排除标准
- •Subject who have bleeding disorder in the past or present
- •Other criteria as identified in the protocol
结局指标
主要结局
The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.
时间窗: from baseline to 24 weeks
Score of WSRS assessed by the independent evaluator
次要结局
- Visual Analogue Scale as evaluated by a subject(week 0 (injection date))
- Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject(2, 8, 16, 24 weeks after week 0 (injection date))
- The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.(from baseline to 2, 8, 16 weeks)
- Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by independent evaluator through Photographs.(from baseline to 2, 8, 16, 24 weeks)
- The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by investigator.(from baseline to 2, 8, 16, 24 weeks)
- Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator(2, 8, 16, 24 weeks after week 0 (injection date))
- Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by the investigator(from baseline to 2, 8, 16, 24 weeks)
研究者
研究点 (2)
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