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临床试验/NCT06218394
NCT06218394招募中不适用

Comparison of Microneedling vs. Autologous Concentrated Growth Factor for the Treatment of Female Androgenetic Alopecia

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2023年12月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
135
试验地点
1
主要终点
TAHC

研究概览

简要总结

Microneedling and autologous concentrated growth factor (CGF) have established their potential effect in inducing hair regrowth. No study has compared the effect of microneedling and CGF in the treatment of female androgenetic alopecia (AGA).

详细描述

Microneedling is a minimally invasive technique consisting of sterile microneedles for repetitive cutaneous puncturing that increase hair regrowth by growth factor release. Concentrated growth factor (CGF) is a form of platelet concentrate (PC) and concentrates higher levels of growth factors because of its varying programmed centrifugation process. Previous studies have showed that CGF injection in hairless scalp could enhance the hair density and optimize the hairless appearance in AGA patients. Both microneedling and CGF have established their potential effect in inducing hair regrowth. No study has compared the effect of microneedling and CGF in the treatment of female androgenetic alopecia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age between 18 and 65 years;;
  • clinical diagnosis of female pattern hair loss;
  • no previous laser treatments for AGA in the past six months before enrollment; 4) willingness to provide pictures and follow-up studies.

排除标准

  • if presented with severe diseases of internal organs, eyes, or skin;
  • inflammation, infection, or unhealed wounds on the skin around the site of treatment on the head;
  • systematic treatment with corticosteroids or other immunosuppressants and immunomodulators in the past 3 months.

研究组 & 干预措施

microneedling

Experimental

干预措施: microneedling (Procedure)

autologous concentrated growth factor

Experimental

干预措施: Autologous Concentrated Growth Factor (Procedure)

5% minoxidil

Active Comparator

干预措施: 5% minoxidil (Drug)

结局指标

主要结局

TAHC

时间窗: week 24

Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .

次要结局

  • IGA(week 8, week 12, week 16, week 24, week 36)
  • Grade of Ludwig and Norwood-Hamilton Classification(week 12, week 24, week 36)
  • TAHC(week 8, week 12, week 20, week 36)
  • HGQA(week 8, week 12, week 16, week 24, week 36)
  • TAHW(week 8, week 12, week 16, week 24, week 36)
  • SSA(week 8, week 12, week 16, week 24, week 36)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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