Prospective Observational Clinical Trial for Safety and Efficacy of HYAPROF® SOFT and HYAPROF® BALANCE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Number of subjects with wrinkle severity improvement 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 HYAPROF® SOFT and HYAPROF® BALANCE 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 HYAPROF® SOFT and HYAPROF® BALANCE 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 HYAPROF® SOFT and/or BALANCE according to the instructions for use of the product
- •decision for the treatment with HYAPROF® SOFT and/or BALANCE 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 either with HYAPROF® SOFT or HYAPROF® BALANCE - no combination of the products in one treated 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
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
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
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
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
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
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
次要结局
- Product safety 3 months(3 months)
- Product safety 4 weeks(4 weeks)
- Product safety immediately after the treatment(Immediately after the treatment)
- Product safety 6 months(6 months)