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临床试验/NCT06209138
NCT06209138已完成不适用

Tailoring of HPMC-Zein Based Film Forming Gel of 5-fluorouracil for Treat-ment of Stable Vitiligo: a Strategy Assisted by Carbon Dioxide Laser Dermabra-sion

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月23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
已完成
入组人数
40
试验地点
1
主要终点
Guartile grading scale

研究概览

简要总结

Vitiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal.

详细描述

Vtiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal. 5FU is a well-known chemotherapeutic agent that has been used for colorectal cancer treatment. The drug prevents DNA synthesis by inhibiting the thymidylate synthetase. The hyperpigmenta-tion of the skin is the most side effect observed with 5-FU therapy which directed its use in treat-ment of vitiligo. Besides, many studies reported that 5-FU could induce regimentation in vitiligo by direct stimulation of melanocytes and increasing melanosomes numbers in the keratinocytes.

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
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with stable vitlligo

排除标准

  • patients under the age of 10 years.
  • Individuals with a history of the Koebner phenomenon, a tendency for keloid or hypertrophic scarring
  • Pregnancy.
  • Recent isotretinoin therapy within the last 6 months.

研究组 & 干预措施

CO2 laser assisted dermabrasion and 5FU film

Experimental

干预措施: 5 fluorouracil (Drug)

CO2 laser assisted dermabrasion and saline

Active Comparator

干预措施: Saline (Other)

结局指标

主要结局

Guartile grading scale

时间窗: 2 months

A grading system with a quartile grading scale was used. Here, grading of \> 75% will be considered excellent improvement, very good (51-75%), good (50-25%), poor (\<25%), mild (25%), and poor improvement if less than 25% grading.

analysis of Jak3 expression in vitiligo lesions

时间窗: 2months

the improvement will be associated with a reduction in JAK levels

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

Mahmoud A Makki, MD

Professor

Al-Azhar University

研究点 (1)

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