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临床试验/NCT02794363
NCT02794363已完成不适用

Autologous Platelet Rich Plasma Intradermal Injections for Vulvar Lichen Sclerosus

Center for Vulvovaginal Disorders0 个研究点目标入组 15 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
主要终点
Decrease in inflammation on post treatment biopsies

研究概览

简要总结

15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic specializing in vulvar disorders. This study consists of a 2 week screening period and a 12-week treatment period. Participants will receive two separate treatments of autologous platelet rich plasma separated by 6 weeks. A repeat biopsy will be performed 6 weeks after the second autologous platelet rich plasma injection

详细描述

15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic specializing in vulvar disorders. This study consists of a 2 week screening period. A 4mm vulvar punch biopsy will be obtained at the initiation of the screening period to confirm that the participant have active lichen sclerosus. 12 weeks after the biopsy, the participants will receive an injection of 5cc of autologous platelet rich plasma into the affected vulvar skin. Six weeks later, participants will receive an additional injection of 5cc of autologous platelet rich plasma. A repeat biopsy will be performed 6 weeks after the second autologous platelet rich plasma injection. The inflammation on both biopsy specimens will be determined by a dermatopathologist.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Active lichen sclerosus
  • no current treatment
  • symptomatic 4/10 on visual analogue scale

排除标准

  • history of vulvar carcinoma or VIN

结局指标

主要结局

Decrease in inflammation on post treatment biopsies

时间窗: 14 weeks

Pathologist will grade inflammation on 0-4 scale of pre and post treatment biopsies

次要结局

  • Investigator Global Assessment(14 weeks)
  • Decrease in Pruritus(14 weeks)

研究者

发起方
Center for Vulvovaginal Disorders
申办方类型
Other
责任方
Sponsor

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