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临床试验/NCT07742982
NCT07742982招募中1 期

Efficacy of Topical Tyrosine Versus Topical 5-Fluorouracil With Fractional Erbium YAG Laser in Focal Vitiligo: A Randomised Clinical Trial

Aswan University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026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
1 期
状态
招募中
入组人数
40
试验地点
1
主要终点
Treatment of Focal Vitiligo

研究概览

简要总结

Vitiligo is an autoimmune disorder affecting the skin, specifically targeting pigment-producing melanocytes, leading to noticeable regions of depigmentation characterized by white spots.

It is a widely prevalent skin disorder globally, affecting males and females almost equally, although it is reported slightly more frequently in females. In more than 60% of patients, the disease begins before the age of 30 and It has an estimated prevalence of roughly 0.2-2% across various populations, with around 0.4% in the European-derived white (EUR) population.

详细描述

Vitiligo is an autoimmune disorder affecting the skin, specifically targeting pigment-producing melanocytes, leading to noticeable regions of depigmentation characterized by white spots. Two major clinical forms of vitiligo are recognized: non-segmental vitiligo, the most common type, usually presenting with symmetrical lesions, and segmental vitiligo, which manifests as unilateral depigmentation.

The exact pathogenesis of vitiligo remains unclear. However, it is believed to be a complex process involving genetic susceptibility, metabolic disturbances related to oxidative stress, impaired melanocyte adhesion to the epidermis, and immune mechanisms including both innate and adaptive immunity, ultimately leading to selective melanocyte destruction. Nevertheless, none of these mechanisms alone can completely explain melanocyte loss, suggesting that vitiligo is a multifactorial disorder.

The management of vitiligo aims to halt disease progression, stimulate repigmentation, and prevent relapse, with repigmentation largely driven by melanocyte stem cells in hair follicles that can migrate and restore functional melanocytes to depigmented areas.

Immune modulators, such as topical steroids, topical calcineurin inhibitiors, phototherapies, and systemic therapy like oral steroids, are the mainstay of traditional treatments. However, these options are still not ideal, which prompts research into novel vitiligo treatments. There is still a need for workable and well-tolerated therapeutic choices, even if treatment must be tailored to each patient and particular lesions.

5-Fluorouracil (5-FU) is a hydrophilic pyrimidine analogue with significant anticancer activity and limited water solubility, first discovered in the 1950s by Heidelberger through the introduction of a fluorine atom at the fifth position of the uracil molecule.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • - Patients with focal vitiligo

排除标准

  • Pregnancy.
  • Lactation.
  • Patients with segmental vitiligo.
  • Patients with autoimmune disease including thyroiditis.
  • Patients with chronic systemic diseases,such as anemia ,diabetes mellitus, immunosuppression, or chronic infections.
  • Patients with active skin infections.

研究组 & 干预措施

L-tyrosine Cream Group

Active Comparator

About 20 cases suffering from Focal Vitiligo will receive 6 sessions of fractional Er:YAG laser at two-week intervals. Starting [immediately ] after each laser session, patients will apply topical L-tyrosine (2% cream) twice daily for two weeks. This continuous application will be maintained between laser sessions and after the final session.

干预措施: Tyrosine (Drug)

Topical 5-Fluorouracil Group

Active Comparator

About 20 cases suffering from Focal Vitiligo will receive 6 sessions of fractional Er:YAG laser at two-week intervals. Starting [immediately ] after each laser session, patients will apply topical 5-fluorouracil (5% cream) once daily for two weeks. This 14-day topical application cycle will be repeated following each of the 6 laser sessions.

干预措施: Tyrosine (Drug)

结局指标

主要结局

Treatment of Focal Vitiligo

时间窗: 1 year

To measure the efficacy of the treatment by Topical Tyrosine and Topical 5-Fluorouracil With Fractional Erbium YAG Laser in repigmentation, assessed by the change in the Vitiligo Area Scoring Index (VASI ) which is determined by summing the products of the number of hand units and the percentage of depigmentation for each lesion, using predefined categories of 0%, 10%, 25%, 50%, 75%, 90%, and 100%. where as 0% is the worst and 100% is the best.

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

Yasmin Mahdy Mohamed

Resident of Dermatology, Venereology and Andrology

Aswan University

研究点 (1)

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