Multicenter, Randomized, Subject & Independent Evaluator-blind, Split-face, Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With JTM102 as Compared to Juvederm VOLUMA With Lidocaine for Temporary Restoring the Mid-face Volume
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Improvement in midface volume
研究概览
简要总结
This study is clinical investigation for evaluating safety and efficacy of JTM102 on temporary correction of mid-face volume deficiency
详细描述
This study is Multicenter, Randomized, Subject & Independent Evaluator-blind, Split-face, Medical Device Pivotal study to evaluate the efficacy and safety of injection with JTM102 as compared to Juvederm VOLUMA with Lidocaine for temporary restoring the mid-face volume
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who voluntarily agree to participate in this clinical trial.
- •Adults aged 19 to 65 years.
- •Subjects who desire temporary improvement of mid-face volume and whose Mid-face volume deficit level meets eligibility criteria
- •Subjects who agree to discontinue all dermatological treatments or procedures for the face during the clinical trial period, including wrinkle improvement treatments such as fillers, botulinum toxin, laser therapy, chemical peels, and cosmetic surgeries, except for the investigational medical device application.
- •Subjects who use medically acceptable contraception methods throughout the clinical trial period (pregnant or breastfeeding women are excluded).
- •Subjects who understand and can comply with the study instructions and can participate for the entire duration of the clinical trial.
排除标准
- •History or concurrent conditions included in exclusion criteria
- •History of procedures (including surgery) included in exclusion criteria
- •Use of medications that may affect evaluation of the investigational device:
- •Any other conditions judged by the investigator as inappropriate for participation in this clinical trial.
研究组 & 干预措施
JTM102
HA filler with lidocaine
干预措施: JTM102 (Device)
Juverderm Voluma with Lidocaine
HA filler with lidocaine
干预措施: Juvederm VOLUMA with Lidocaine (Device)
结局指标
主要结局
Improvement in midface volume
时间窗: 24 weeks after final application of the investigational medical device
Facial volume deficiency was graded using 6-point Facial Midvolume Measuring Scale with higher scores indicating greater severity of gauntness. The proportion of subjects whose score decreased from baseline, as assessed by independent photographic evaluators, was calculated.
MFVDS
时间窗: 24 weeks after final application of the investigational medical device
Improvement rate in the Mid-Face Volume Deficit Scale (MFVDS), as assessed by independent photographic evaluators, compared to baseline.
次要结局
未报告次要终点