NCT07150273已完成不适用
A Randomized, Single-Center, Patient & Evaluator-Blind, Matched Pairs, Active-Controlled Design Confirmatory Clinical Study to Evaluate the Efficacy and Safety of the Injection With UNIVELO Sub-Q, as Compared to Restylane® Sub-Q, in the Temporary Correction of the Nasolabial Fold
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Wrinkle Severity Rating Scale (WSRS)
研究概览
简要总结
A 48-week, single-center, randomized, patient & evaluator-blind, matched pairs, active-controlled, non-inferiority, confirmatory design
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
- •Subjects who desire temporary improvement of both nasolabial folds and who has rated 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) (the rating does not have to be the same for both sides)
- •Subjects who have agreed to discontinue all dermatological treatments or procedures, including those for facial wrinkles improvement in the facial area, during the clinical trial period
- •Subjects capable of understanding and complying with directions and who can participation for the full duration of the clinical trial period
- •Subjects who have voluntarily decided to participate in the clinical trial and have given written consent by signing the subject informed consent form
排除标准
- •Subjects who have been administered an antithrombotic agent (with the exception of low dosage aspirin (100mg, maximum 300mg/day)) within 2 weeks of the date of the screening
- •Subjects who have had a history of any bleeding disorder, in the past or the present
研究组 & 干预措施
Test Device - UNIVELO Sub-Q
Experimental
UNIVELO Sub-Q
干预措施: UNIVELO Sub-Q 2mL (Device)
Comparator Device - Restylane Sub-Q
Active Comparator
Restylane Sub-Q
干预措施: Restylane Sub-Q 2mL (Device)
结局指标
主要结局
Wrinkle Severity Rating Scale (WSRS)
时间窗: 24 weeks
Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)
Wrinkle Severity Rating Scale (WSRS)
时间窗: 24 weeks
Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)
次要结局
- Wrinkle Severity Rating Scale (WSRS)(8 weeks, 16 weeks, 36 weeks, 48 weeks)
- Global Aesthetic Improvement Scale (GAIS)(8 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks)
- Wrinkle Severity Rating Scale (WSRS)(8 weeks, 16 weeks, 36 weeks, 48 weeks)
- Global Aesthetic Improvement Scale (GAIS)(8 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks)
研究者
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