NCT07412392尚未招募不适用
A Multi Center, Randomized, Subject & Independent Evaluator-blinded, Matched Pairs, Active Controlled, Non-inferiority, Pivotal Study to Evaluate the Efficacy and Safety of Injection With DIOSHA S Lido as Compared to YOUTHFILL(YOUTHFILL Fine With Lidocaine) in Temporary Correction of Moderate to Severe Nasolabial Folds
Hyundae Meditech0 个研究点目标入组 60 人开始时间: 2026年2月27日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Change from Baseline in Nasolabial Fold Severity Score at Week 24
研究概览
简要总结
Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe 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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 19 to 75 years
- •Voluntarily provided written informed consent
- •Moderate to severe symmetrical nasolabial folds (WSRS score 3 or 4 on both sides)
- •Agree to discontinue other facial dermatologic treatments (e.g., fillers, botulinum toxin, laser) during the study
- •Able to understand instructions and comply with study procedures
排除标准
- •Active facial skin disease, infection, or untreated scars in the treatment area
- •History of severe allergy or hypersensitivity to device components
- •Facial aesthetic or invasive procedures in the treatment area within 6 months prior to screening
- •Use of prohibited medications within required washout periods
- •Participation in another interventional clinical trial within 4 weeks prior to screening or during the study
- •Pregnancy, breastfeeding, or non-compliance with contraception requirements
- •Any condition deemed inappropriate by the investigator
研究组 & 干预措施
YOUTHFILL Fine with Lidocaine Injection
Active Comparator
干预措施: YOUTHFILL Fine with Lidocaine (Device)
DIOSHA S Lido Injection
Experimental
干预措施: DIOSHA S Lido (Device)
结局指标
主要结局
Change from Baseline in Nasolabial Fold Severity Score at Week 24
时间窗: Baseline to Week 24
次要结局
- Change from Baseline in Nasolabial Fold Severity Score at Week 48(Baseline to Week 48)
研究者
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