A Prospective, Multicentric, Open Label, Bio Interventional, Phase I, Phase II Pilot Study to Evaluate the Safety and Efficacy of Autologous Human Platelet Lysate (HPL) for Treatment of Acne Scarring
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Changes in the Global Acne scarring classification
研究概览
简要总结
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Acne Scarring. The study is being conducted at 2 centers in India. The primary endpoint is change in the Global Acne scarring classification scores from screening to end of the study. The secondary endpoints are Photographic Assessment, Physicians assessment score and Patients self assessment score.
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 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).
- •Subject willing to refrain from any other treatment of Acne Scarring during entire study duration.
- •Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study.
- •Subjects who are willing to give informed consent and adhere to the study protocol.
排除标准
- •Subjects with active infection or active acne.
- •Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study.
- •Subjects with history of connective tissue disease.
- •Subjects with metabolic or hematopoietic disorders.
- •Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia.
- •Subjects who have received prior chemotherapy and radiotherapy
- •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 arm A
Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring
干预措施: Autologous Human Platelet Lysate (Biological)
Study arm B
Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring.
干预措施: Autologous Human Platelet Lysate (Biological)
结局指标
主要结局
Changes in the Global Acne scarring classification
时间窗: Day 0, End of study - Month 3
次要结局
- Photographic Assessment(Day 0, Month 1, Month 2 End of study - Month 3)