NCT01644448Unknown1 期
A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate (HPL) for Treatment of Periorbital Hyperpigmentation (Dark Circles)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Photographic Assessment
研究概览
简要总结
This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. The secondary endpoints are improvement in photographic assessment form randomization to end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation.
- •Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration.
- •Subjects who are willing to give informed consent and adhere to the study protocol.
排除标准
- •Subjects aged less than 18 and more than 55 years
- •Subjects with history of connective tissue disease.
- •Subjects with metabolic or hematopoietic disorders
- •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 30 days.
研究组 & 干预措施
Control Arm B
Other
Topical Applications of the standard therapy as directed by the investigator
干预措施: Standard Therapy (Other)
Study arm A
Other
Subjects will receive one dose of 5 ml of Autologous Human Platelet Lysate with simultaneous micro-needling on day 2
干预措施: Autologous Human Platelet Lysate (Other)
结局指标
主要结局
Photographic Assessment
时间窗: Day 0, Month 1, Month 2, End of Study - 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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