Prospective Observational Clinical Trial for Safety and Efficacy of HYAcorp Lips and HYAcorp Face
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- Wrinkle severity assessment 3 months
研究概览
简要总结
Purpose of this study is the demonstration of safety and efficacy of the dermal fillers HYAcorp Lips and HYAcorp Face for restoration of the facial volume and contour.
详细描述
This is a prospective, multicenter, observational, open label, two-arm, crossover, PMCF clinical trial for demonstration of the safety and efficacy of the HA-based dermal fillers HYAcorp Lips and HYAcorp Face for restoration of the facial volume and contour. Besides safety aspects, evaluated immediately after the treatment, 4 weeks, 3 and 6 months after the treatment, the performance of the demal fillers are evaluated in the 3 and 6 months follow-up by using GAIS and WSRS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •subjects intended for the treatment with HYAcorp Lips and/or Face according to the instructions for use of the product
- •decision for the treatment with HYAcorp Lips and/or Face was made before the subject was recruited for the clinical trial
- •subjects signed written informed consent
- •adult subjects at least 18 years old
- •all Fitzpatrick skin types
- •area treated with one investigational device - no combination of products in one treatment area
排除标准
- •tendency to hypertrophic and keloid scarring
- •intolerance to gram-positive bacteria
- •prone to active inflammatory or infectious processes
- •suffering from acute or chronic skin diseases
- •undergoing anti-coagulant therapy
- •known allergy to hyaluronic acid
- •suffering from autoimmune diseases
- •multiple allergies
- •pregnancy or lactating women
- •subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits
结局指标
主要结局
Wrinkle severity assessment 3 months
时间窗: 3 months
Wrinkle severity assessment acc. to the Wrinkle Severity Rating Scale (WSRS); 1: wrinkles absent, 2: slight wrinkles, 3: moderate wrinkles, 4: severe wrinkles, 5: very severe wrinkles
Global aesthetic improvement 6 months
时间窗: 6 months
Global aesthetic improvement assessment acc. to the Global Aesthetic Improvement Scale (GAIS); 3: very much improved, 2: much improved, 1: improved, 0 unchanged, -1: worse
Wrinkle severity assessment 6 months
时间窗: 6 months
Wrinkle severity assessment acc. to the Wrinkle Severity Rating Scale (WSRS); 1: wrinkles absent, 2: slight wrinkles, 3: moderate wrinkles, 4: severe wrinkles, 5: very severe wrinkles
Global aesthetic improvement 3 months
时间窗: 3 months
Global aesthetic improvement assessment acc. to the Global Aesthetic Improvement Scale (GAIS); 3: very much improved, 2: much improved, 1: improved, 0 unchanged, -1: worse
Number of subjects with wrinkle severity improvement 3 months
时间窗: 3 months
Number of subjects with at least one scale point improvement in the wrinkle severity assessment (WSRS) with respect to baseline
Number of subjects with wrinkle severity improvement 6 months
时间窗: 6 months
Number of subjects with at least one scale point improvement in the wrinkle severity assessment (WSRS) with respect to baseline
次要结局
- Product safety 6 months(6 months)
- Product safety immediately after the treatment(Immediately after the treatment)
- Product safety 4 weeks(4 weeks)
- Product safety 3 months(3 months)