A Prospective, Multicentric, Open Label, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment of Facial Wrinkles (Nasolabial Folds)
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile
研究概览
简要总结
This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in photographic assessment, Physician's assessment scores, Patient's assessment scores form enrollment to end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects (male and female), aged 18 to 40 years (both inclusive).
- •Subjects willing to refrain from any other treatment for Nasolabial Folds.
- •Subjects who are willing to give informed consent and adhere to the study protocol.
排除标准
- •Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc
- •Subjects with history of Connective tissue disease
- •Subjects with autoimmune diseases
- •Subjects unwilling to or unable to comply with the study protocol.
- •Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days
研究组 & 干预措施
Study Group
All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region
干预措施: Autologous Human Platelet Lysate (Other)
结局指标
主要结局
Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile
时间窗: Day 0, End of Study - 3 months
次要结局
- Global Aesthetic Improvement Scale(Day 0, End of study - Month 3)