NCT07618468已完成不适用
A Single-center Clinical Study of the Efficacy and Safety of the Medical Device "Algeness Subdermal Implant Based on Agarose (Ghimas SpA/Ghimas SpA, Italy) in the Correction of Skin Contour Defects.
Estelab Clinic1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
A single-center clinical study of the efficacy and safety of the medical device "Algeness subdermal implant based on agarose (Ghimas SpA/Ghimas SpA, Italy) in the correction of skin contour defects.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 30 and 65 years inclusive
- •Presence of signs of age-related facial skin changes (decreased turgor, elasticity, fine wrinkles, contour defects)
- •Signed informed voluntary consent
- •Willingness and ability to comply with study procedures and attend all scheduled visits
排除标准
- •Age under 18 years
- •Individual intolerance or allergy to any component of the investigational device
- •Diagnosed tendency to keloid or hypertrophic scarring
- •Severe chronic diseases in the acute phase
- •Acute forms of dermatological diseases
- •Coagulation disorders
- •Treatment with medications affecting blood coagulation
- •Inflammatory or infectious processes in the injection zones
- •Diagnosed autoimmune pathologies
- •Pregnancy and lactation period
- •Filler injections in the same area within the past 12 months
- •Laser procedures or chemical peels within the past 3 months
- •Oncological diseases in history or at the time of inclusion
- •Participation in another clinical study within the past 3 months
研究者
Chebotareva Yulia Yurievna
Principal Investigator
Estelab Clinic
研究点 (1)
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