A Single-center Clinical Study of the Efficacy and Safety of the Medical Device "Intradermal Implant, Sterile ULTRACOL Based on Polydioxanone (ULTRA V Co., Ltd., Korea) in the Correction of Skin Contour Defects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
研究概览
简要总结
Study of the effectiveness of the medical device "Intradermal implant, sterile ULTRACOL based on polydioxanone (ULTRA V Co., Ltd., Korea) in the correction of skin contour defects.
详细描述
The investigational product is composed of a mixture of polydioxanone and sodium carboxymethylcellulose. The polydioxanone content is as follows: Ultracol 200: 150 mg ±10%, Ultracol 100: 75 mg ±10%. The key difference from the closest analogs (AestheFill® V200, Sculptra™, Ellagen PLLA+CMC 1000 mg) is the presence of polydioxanone in the investigational product.
Thus, the analyzed analogues are not fully interchangeable medical products. The combined composition of Ultracol has not been studied properly. Therefore, during the clinical study, it is necessary to check the safety and effectiveness of a medical product with a combined composition - polydioxanone and sodium carboxymethylcellulose.
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
- •The subject has indications for use according to the manufacturer instructions for the device.
- •The subject is at least 18 years old at the time of signing the informed consent.
- •The subject expresses willingness and ability to follow the requirements of the study protocol.
- •The subject has no contraindications described in the device instructions for use.
排除标准
- •The subject has at least one contraindication described in the device instructions for use, based on initial examination, laboratory tests and medical history.
- •Women of reproductive age: pregnancy, planning pregnancy during the study period, or breastfeeding.
- •Use of another product for the same indication during the clinical study.
- •Participation in another clinical study.
- •Pre-existing health problems that may compromise compliance with the study protocol.
- •Patients prone to excessive scarring.
- •Patients undergoing chemotherapy.
- •Patients previously treated with intradermal fillers in the planned injection zone with persistent effect.