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临床试验/NCT05467839
NCT05467839已完成不适用

Evaluation of Efficacy of Microneedling and Topical Methotrexate Versus Microneedling and Topical 5-flourouracil in Treatment of Vitillgo Patients

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7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
percentage of repigmentation

研究概览

简要总结

Vitiligo is a depigmenting skin disorder, characterized by the selective loss of melanocytes, which in turn leads to loss of pigment in the affected areas of the skin It considerd as autoimmune disease, associated with genetic and environmental factors together with metabolic, oxidative stress and cell detachment abnormalities The disease affects both genders equally, it can appear at any age, and the average age of onset is somewhat variable in different geographic . with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide 5-Flourouracil is an antimetabolite analogue of the naturally occurring pyrimidine uracil which is metabolised via the same metabolic pathways as uracil Due to its antimitotic activity, topical 5-Flourouracil is a useful therapy for the treatment of many dermatological disorders characterized by a high mitotic rate Clinically, localized hyperpigmentations have been reported during systemic treatment of various cancers by 5-Flourouracil. Usually, these hyperpigmented lesions are located on the normally pigmented extremities (hands and feet) and tongue.

Methotrexate as an antimetabolite and antifolate drug is a time-tested effective treatment extensively used in various autoimmune disorders in low to moderate doses with good efficacy, safety, and tolerability on a long-term basis .

Methotrexate treatment resulted in the decrease of the number of TNF-α-producing T cells, whereas the number of T cells producing IL-10 after polyclonal activation increased, in another study .

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
All
接受健康志愿者
否

入选标准

  • •• Age :main 18 and above years old.
  • •Stable vitiligo (each patient has 3separated patches of depigmentation at least).

排除标准

  • •History of keloid formation.
  • •Patients with systemic diseases (diabetes, bleeding disorders)
  • •Patients who are receiving chemotherapy or radiotherapy

研究组 & 干预措施

vitillgo patients

Experimental

干预措施: derma pen (Device)

结局指标

主要结局

percentage of repigmentation

时间窗: 6 months

dermoscopic evaluation

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

Fatma Kassem Ali

Resident of dermatology and venerology at Sohag general hospital

Sohag University

研究点 (1)

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