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临床试验/NCT05989165
NCT05989165已完成3 期

Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men

Indonesia University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
36
试验地点
1
主要终点
Density of hair

研究概览

简要总结

The goal of this clinical trial is to compare the effectiveness of combination therapy of microneedling and minoxidil in androgenetic alopecia of Indonesian men. The main questions it aims to answer are:

  • Is there an increase in hair density with combination therapy of microneedling and minoxidil versus minoxidil monotherapy?
  • Is there an increase in hair diameter with combination therapy of microneedling and minoxidil versus minoxidil monotherapy?

Participants will be divided into 2 groups. The first one will receive minoxidil monotherapy, and the second one will receive a combination therapy of microneedling and minoxidil. Researchers will compare those 2 groups to see if there is a difference of effectiveness based on hair density and diameter.

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 59 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Indonesian
  • Age 18-59 years
  • Diagnosis of androgenetic alopecia
  • Hamilton-Norwood type III-IV

排除标准

  • Use of minoxidil or finasteride topical 1 month prior
  • Use of minoxidil or finasteride oral 1 month prior
  • Skin infection in the treatment area
  • Cosmetic procedures for the treatment of alopecia androgenetic such as platelet rich plasma, laser therapy,or microneedling 3 months prior
  • History of keloid

研究组 & 干预措施

Minoxidil 5% solution

Experimental

Patients will receive minoxidil 5%, twice a day, for a total duration of 12 weeks.

干预措施: Minoxidil 5% Topical Solution (Drug)

Combination therapy of microneedling and minoxidil 5% solution

Experimental

Patients will receive a combination therapy of microneedling and minoxidil 5%. Minoxidil 5%, will be given twice a day for a total duration of 12 weeks. The microneedling treatment will be given every 4 weeks (week 0, week 4, week 8)for a total duration of 12 weeks.

干预措施: Minoxidil 5% Topical Solution (Drug)

Combination therapy of microneedling and minoxidil 5% solution

Experimental

Patients will receive a combination therapy of microneedling and minoxidil 5%. Minoxidil 5%, will be given twice a day for a total duration of 12 weeks. The microneedling treatment will be given every 4 weeks (week 0, week 4, week 8)for a total duration of 12 weeks.

干预措施: microneedling (Device)

结局指标

主要结局

Density of hair

时间窗: 12 weeks

Increase density of hair in alopecia androgenetic patient

Diameter of hair

时间窗: 12 weeks

Increase diameter of hair in alopecia androgenetic patient

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

Kara Adistri

MD

Indonesia University

研究点 (1)

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