"Clinical and Instrumental Evaluation of the Safety and Bio-revitalizing Effect on the Face of the Medical Device 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety: no adverse events
研究概览
简要总结
Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 40 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events
详细描述
The patients chosen with facial laxity characteristics, at the first visit will be assessed and will receive the treatment (microinjections) in the cheekbone area, over the lips and in the marionette lines. After 4 weeks the first visit will assess the change of the tissutal structure with non invasive measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •all sexes
- •18 to 70 years
- •non smoker
排除标准
- •Pregnancy
- •alcohol or drugs abuse
- •change of BMI during the study
- •previous facial surgery, implants, permanent treatments
- •sensitivity to the product
- •dermatological difficult frame
- •health weakness
- •treated with anticoagulants, antihistaminics, corticosteroids, antidepressants and other drugs impacting on the results
研究组 & 干预措施
Face treatment
Patients treated for face needs with Karisma micro injections
干预措施: Karisma (Device)
Lips treatment
Patients treated for face needs with Karisma microinjections
干预措施: Karisma (Device)
结局指标
主要结局
Safety: no adverse events
时间窗: 16 weeks
test the safety of the device evaluating any potential adverse event
Efficacy: change of wrinkles and scars
时间窗: 16 weeks
test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale
次要结局
- Duration of the efficacy(16 weeks)