Non-interventional Study: Collagen Anti-age Treatment in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Elastisity Ultrasonic scanning of the scin - epidermis and dermis in 3 area of the face after injections of the Collagen and after injections of the Hyaluronic Acid
研究概览
简要总结
This study evaluates the statistics of anti-age treatment in outpatient sites in Russia (involution indicators: clinical scales; instrumental diagnostics, ultrasonic scannings, assesment of allergic state, efficacy assesment in according with GAIS scale) in routine clinical practice with focus on collagen therapy.
详细描述
This non-interventional study covers 60 patients (females with involuntary changes of the face skin) from Russian sites.
The following data will be collected and analyzed after the end of treatment:
- demography
- assessment of allergic state
- safety data
- severity of aging effect
- clinical scales results before 1visit and after end of treatment
- GAIS effectiveness assessment
- instrumental diagnostic before 1visit and after end of treatment
- hydration
- elasticity
- microcirculation level
- lipofuscin level
- ultrasound scanning
- derma echo density
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •signed Inform Consent Form
- •only females
- •from 35 to 65 years old
- •1-3 skin photo types
- •signs of age-related skin changes
- •absence of chronic disease in decompensation phase
- •refusal to receive any cosmetic procedures during the study
排除标准
- •pregnancy, lactation period
- •infection process, dermatoses, censers
- •systemic connective tissue diseases with skin and subcutaneous tissue damage
- •taking isotretinoin drugs for the previous 6 months
- •propensity to form hypertrophic and keloid scars
- •exacerbation or decompensation of chronic somatic diseases; infectious and oncological diseases
- •violations of blood coagulation, including iatrogenic (taking drugs that affect blood clotting)
- •taking antihistamines, glucocorticoids, NSAIDs, immunosuppressants and other drugs that affect the reactivity of the skin
- •hypersensitivity to the components of the studied medical device
研究组 & 干预措施
Collagen injections
30 females with aging facial problems from 35 to 65 years old prescribed collagen ingection once every 3 weeks, cours of therapy - 3 procedures
干预措施: Collagen for injections 7% (Device)
Hyaluronic acid injections
30 females with aging facial problems from 35 to 65 years old prescribed hyaluronic acid ingection once every 3 weeks, cours of therapy - 3 procedures
干预措施: Hyaluronic acid for injections 2% (Device)
结局指标
主要结局
Elastisity Ultrasonic scanning of the scin - epidermis and dermis in 3 area of the face after injections of the Collagen and after injections of the Hyaluronic Acid
时间窗: 3 months
To evaluate elasticity in Cheek, in forehead and glabella area scanned after each procedure and compare with screening results
次要结局
- Safety: to evaluate safety by comparing adverse events after injections of the Collagen and after injections of the Hyaluronic Acid(3 months)
- Microcirculation data after injections of the Collagen and after injections of the Hyaluronic Acid(3 months)
- GAIS scale data after injections of the Collagen and after injections of the Hyaluronic Acid(3 months)
- 3D photo materials after injections of the Collagen and after injections of the Hyaluronic Acid(3 months)