CTRI/2012/04/002549已完成1/2 期
A Prospective, Multicentric, Open Label, Randomized, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) for Treatment of Periorbital Hyperpigmentation (Dark Circles)
KASIAK RESEARCH PRIVATE LIMITED2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年3月20日最近更新:
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
- •Physician’s assessment scores
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
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation.
- •2.Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration.
- •3.Subjects who are willing to give informed consent and adhere to the study protocol.
排除标准
- •1.Subjects aged less than 18 and more than 55 years 2.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.
结局指标
主要结局
•Physician’s assessment scores
时间窗: End of Study - 3Months
•Patient’s assessment scores
时间窗: End of Study - 3Months
次要结局
- •Photographic assessments(End of Study - 3 Months)
研究者
研究点 (2)
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