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临床试验/NCT01590238
NCT01590238已完成3 期

Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

The New York Eye & Ear Infirmary2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
15
试验地点
2
主要终点
Hair Density Change After Three Treatments

研究概览

简要总结

Clinical alopecia occurs due to miniaturization of the hair shafts as well as loss of active production of hair shafts. PRFM has been shown to induce dermal angiogenesis, and anecdotal findings of improvement of hair appearance after PRFM injection in the scalp suggest that PRFM may play a role in the treatment of thinning hair. Patients will be treated on a monthly basis with intradermal injections of autologous PRFM for 3 months. Changes in hair density will be assessed by comparing pre- and post-treatment photographs and non-invasive measurements of hair density at 1, 2, 3, 4 and 6 months after initial treatment.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18- 75 years old
  • frontal and/or crown alopecia

排除标准

  • bleeding disorder

结局指标

主要结局

Hair Density Change After Three Treatments

时间窗: 6 months after initial visit

Hair density index at calibrated distance from glabella in a 2 cm x 2 cm midline square at 6 month follow up visit as a percentage of initial (pre-treatment) hair density index, measured using a proprietary hair densitometer.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anthony P. Sclafani

Director of Facial Plastic Surgery

The New York Eye & Ear Infirmary

研究点 (2)

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