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临床试验/NCT06440655
NCT06440655招募中不适用

A Randomized, Split-head Comparison Study of the Efficacy and Safety of Platelet-rich Fibrin and Platelet Rich Plasma in Female Pattern Hair Loss Patients : A Pilot Study

Siriraj Hospital4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
4
主要终点
Trichoscan

研究概览

简要总结

The goal of this clinical trial is to compare between platelet-rich fibrin and platelet-rich plasma in female pattern hair loss . The main question[s] it aims to answer are:

  • efficacy between platelet-rich fibrin and platelet-rich plasma
  • safety between platelet-rich fibrin and platelet-rich plasma Participants will be divided into 2 side of treatment with composed of
  1. Platelet rich plasma
  2. Platelet rich fibrin

详细描述

Subject was treated both platelet-rich fibrin and platelet-rich plasma for 3 times which 1 month interval then will be followed up at 4 months and 6 months after last 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
20 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 20-55 years
  • Subject who was diagnosed with Female pattern hair loss in Ludwig Classification 2 (part width 2-4 centimeters) by Dermatologist

排除标准

  • Pregnancy or Lactation subjects
  • Subject with history of platelet dysfunction, low platelet, anemia, cirrhosis, cancer, or immunocompromised host
  • Subject who are active smoking and alcoholism
  • Subject who has dermatitis, scar or infection at intervention area
  • Subject who has history of allergy to anesthesia drug
  • Subject who taking NSAIDs, Hormonal drug, anticoagulants drug
  • Subject who has psychiatric condition diagnosed by psychiatrist
  • Subject who are not allowed to take a photo

结局指标

主要结局

Trichoscan

时间窗: baseline(week0), 4 months after last treatment(week20), 6 months after last treatment(week28)

Average counts and density of hair per 1.5mm\^2

次要结局

  • Visual analog scale(baseline(week0), 1 month after first treatment(week4), 1 months after second treatment(week8))
  • The 7-point of doctor subjective global assessment(baseline(week0),1 month after first treatment(week4), 1 months after second treatment(week8), 4 months after last treatment(week20), 6 months after last treatment(week28))
  • The 7-point of patient subjective global assessment(baseline(week0),1 month after first treatment(week4), 1 months after second treatment(week8), 4 months after last treatment(week20), 6 months after last treatment(week28))

研究者

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

Rattapon Thuangtong

Associate Professor

Siriraj Hospital

研究点 (4)

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