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临床试验/NCT05485571
NCT05485571Unknown不适用

Efficacy of Combined Microneedling With Methotrexate in Treatment of Alopecia Areata

Sohag University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
regrowth scale

研究概览

简要总结

Alopecia areata (AA) is a common cause of non-cicatricial hair loss It is the second-most frequent non-scarring alopecia, after androgenic alopecia.

The prevalence of the disease is 0.2% in the general population with higher prevelance in younger (21-40 years of age) patients but no significant difference in incidence between males and females.

Several treatment options such as corticosteroids, anthralin, topical minoxidil, immunotherapy, and systemic therapy are commonly used with varying response . Unfortunately the traditional treatment options are frequently disappointing Available treatments may induce regrowth but do not modify the disease course .

Methotrexate (MTX) is a folic acid analog that binds to the dihydrofolate reductase enzyme, blocking the formation of tetrahydrofolate and so inhibits purine and pyrimidine metabolism and consequently nucleic acid synthesis. It acts as an immunosuppressant used in the treatment of several skin diseases Systemic MTX has been used in the treatment of AA, with satisfactory results. Microneedling is a minimally invasive procedure that utilizes multiple fine needles to create micropunctures in the skin.The act of creating these two to four cell-wide puncture holes triggers neovascularization, release of growth factors, and stimulates the expression of Wnt proteins. it has specifically been demonstrated to increase hair regrowth in alopecia via the release of platelet-derived growth factor, epidermal growth factors and activation of the hair bulge, all of which are triggered by the wound healing response .Increased expression of Wnt proteins, namely Wnt3a and Wnt10b, is also evident following microneedling. These particular proteins have been demonstrated to stimulate dermal papillae stem cells and hair growth.

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The study will include patients with alopecia areata

排除标准

  • Children below 18 years , pregnant and lactating women .
  • patients with chronic hepatic, hematological disorders or immunocompromised patients.
  • patient recieved any treatment for alopecia areata in the last 3 months before the study.
  • patients with extensive types (alopecia totalis, universalis and surface area >50%).

结局指标

主要结局

regrowth scale

时间窗: 6 months

0 score (regrowth \< 10%) no response 1. score (regrowth 11-25%) poor response 2. score (regrowth 26-50%) fair response 3. score (regrowth 51-75%) satisfactory response 4. score (regrowth ≥ 75%) excellent response

Mcdonald Hull and Norris Regrowth Scale (by trichoscope)

时间窗: 6 months

Grade 1 - Regrowth of vellus hair. Grade 2 - Regrowth of sparse pigmented terminal hair. Grade 3 - Regrowth of terminal hair with patches of alopecia with patches of alopecia 50-75% in SALT score. Grade 4 - Regrowth of terminal hair on scalp with patches of alopecia \> 75% in SALT score.

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

Asmaa Awad Hassanin

resident doctor at Dematology, Venereology and Andrology department at Gerga Hospital

Sohag University

研究点 (1)

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