Multicenter, Randomized, Subject & Independent Evaluator-blind, Matched Pairs, Active-controlled, Non-inferiority, Pivotal Study to Evaluate the Efficacy and Safety of Injection With JTM104 as Compared to Juvederm® ULTRA PLUS XC in Temporary Correction of Moderate to Severe Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- AE
研究概览
简要总结
Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds
详细描述
Multicenter, Randomized, Subject & Independent Evaluator-blind, Matched pairs, Active-controlled, Non-inferiority, Pivotal study to evaluate the Efficacy and Safety of Injection with JTM104 as Compared to Juvederm® ULTRA PLUS XC in temporary correction of 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
- 否
入选标准
- •Adults aged 19 to 75 years
- •Voluntarily provided written informed consent
- •Moderate to severe symmetrical nasolabial folds (score 3 or 4 on a 5-point severity scale 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
- •Untreated scars or facial skin infections/diseases affecting the mid/lower face within the past year
- •History of severe allergy or hypersensitivity to device components
- •Facial invasive procedures within the past 6 months (including surgery, laser, botulinum toxin)
- •Use of certain medications (anticoagulants, immunosuppressants, steroids) within specified washout periods
- •Participation in other interventional clinical trials within 4 weeks before screening or during study
- •Non-compliance with contraception requirements or pregnancy/lactation during study
- •Deemed unsuitable by investigator for any other reason
研究组 & 干预措施
Juvederm® ULTRA PLUS XC
HA Filler
干预措施: Juvederm® ULTRA PLUS XC (Biological)
JTM104
HA Filler
干预措施: JTM104 (Biological)
结局指标
主要结局
AE
时间窗: From adverse event onset through resolution or stabilization, up to 30 days post-study completion
Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved.
SAE
时间窗: From adverse event onset through resolution or stabilization, up to 30 days post-study completion
Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved.
Solicited local AE
时间窗: Within 2 weeks after device application
Local adverse events occurring at the application site within 2 weeks after device use, including pain, swelling, redness, bruising, and other injection site reactions.
次要结局
未报告次要终点