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
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- •Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest
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
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects (male and female), aged 18 to 40 years (both inclusive).
- •2.Subjects willing to refrain from any other treatment for Nasolabial Folds.
- •3.Subjects who are willing to give informed consent and adhere to the study protocol.
排除标准
- •1.Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc 2.Subjects with history of Connective tissue disease
- •Subjects with autoimmune diseases
- •Subjects unwilling to or unable to comply with the study protocol.
- •5.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.
结局指标
主要结局
•Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest
时间窗: End of Study - 3 Months
•Global Aesthetic Improvement Scale (GAIS )
时间窗: End of Study - 3 Months
•Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading on full smile
时间窗: End of Study - 3 Months
次要结局
- •Photographic Assessment(•Physician’s assessment scores)