PMCF Investigation of Medical Device ChitoCare® Medical
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Significant improvement in Vancouver Scar Scale (VSS)
研究概览
简要总结
This is a post-marketing observational clinical investigation conducted as part of the post-market clinical follow-up of ChitoCare® Medical, aimed to confirm safety and efficacy according to the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, for the following indications:
Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne
Spray - conditions after dermatosurgical procedures, dermatitis, acne
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Significant improvement in Vancouver Scar Scale (VSS)
时间窗: 3 months
For scars and conditions after dermatosurgical procedures, efficacy is defined as a significant improvement in Vancouver Scar Scale (VSS) scores from baseline after 3 months of treatment.
Significant improvement in Comprehensive Acne Severity Scale (CASS)
时间窗: 2 months
For acne, efficacy is defined as a significant improvement in the severity rating of patients' acne using the Comprehensive Acne Severity Scale (CASS) from baseline after 2 months of treatment.
Significant improvement in dermatitis severity scale
时间窗: 2 months
For dermatitis, efficacy is defined as a significant improvement in the severity dermatitis severity scale after 2 months of treatment.
次要结局
- Confirmation of safety (adverse events)(2-3 months)
- Confirmation of safety (serious adverse events)(2-3 months)
- Quality of life assessment (adults)(2-3 months)
- Quality of life assessment (children)(2-3 months)