A Prospective, Open-label, Multicenter, Interventional Study, to Evaluate Safety and Efficacy of TCRM in the Treatment of the Cheek Area Including Fine Lines: SPARKS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Teoxane SA
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- To demonstrate the efficacy of TCRM in the treatment of the cheek area including fine lines at 4 weeks after last injection (initial injection or touch up) using Global Aesthetic Improvement Scale (GAIS) as assessed by both subject and PI.
研究概览
简要总结
The purpose of this clinical study is to evaluate benefits and risks of injecting TCRM in the cheek including fine lines. The goal is to show that treatment with TCRM will result in correcting the cheek area including the fine lines at 4 weeks after last treatment (initial injection or touch up) on subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult subjects over 18 years old seeking correction of the cheek area including fine lines.
- •Subject scored grade 1 to 3 on the CFLDS.
- •For women: not pregnant, not breast feeding
- •Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
- •Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
- •Able to follow study instructions and complete all required visits.
- •Having given its signed informed consent.
排除标准
- •Known hypersensitivity or previous allergic reaction to any component of the study devices
- •Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
- •History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
- •Subject exhibits any physical attribute that may prevent assessment or treatment of the cheek area including fine lines as judged by the PI
- •Clinically significant alcohol or drug abuse.
- •Subject has received any investigational product within 90 days prior to Visit 1 or planning to participate in another investigation during the course of the study.
- •Subject has unstable weight, as judged by the PI.
- •Subject has no teeth or misses significant portion of dentition that changes the face appearance (subjects with dentures sufficiently replacing missing natural teeth are allowed).
- •Subject under guardianship/tutorship
结局指标
主要结局
To demonstrate the efficacy of TCRM in the treatment of the cheek area including fine lines at 4 weeks after last injection (initial injection or touch up) using Global Aesthetic Improvement Scale (GAIS) as assessed by both subject and PI.
时间窗: 4 weeks after last injection
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse"
次要结局
未报告次要终点