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
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
- 是
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
干预措施: 5 fluorouracil (Drug)
CO2 laser assisted dermabrasion and saline
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
Mahmoud A Makki, MD
Professor
Al-Azhar University
