Development and Clinical Evaluation of Topical 5-Fluorouracil Effervescent Powder Formulation in the Treatment of Vitiligo
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation
研究概览
简要总结
A novel approach for 5-Fluorouracil delivery based on a solid effervescent formulation is proposed . 5-Fluorouracil is water soluble (~50mg/ml) and therefore has been used for the development of novel topical formulations including nano and microparticles intended for skin targeting. After hydration 5-Fluorouracil could form a complex, a suspension or even be formulated to generate effervescence. In effervescent technology, gas bubbles occur from the liquid after chemical reaction between alkali salts and organic acids (mainly citric or tartaric. Due to liberation in CO2 gas, the dissolution of drug in water is enhanced. The aim of this study is the development and clinical evaluation of topical 5-florouracil effervescent powder formulation in the treatment of vitiligo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will be diagnosed as localized stable vitiligo.
- •Age older than 10 years
- •Stability of lesions for a duration of at least 1 year.
- •Patients who didn't receive treatment for vitiligo in the previous 6 weeks before starting the study.
- •Patients who agreed to join the study and signed written consent and continued till the end of the follow up period
排除标准
- •Patients with vitiligo patches on mucous membrane,
- •Patients with Koebner phenomenon,
- •Other uncontrolled systemic illnesses
- •Patients receiving any systemic or topical treatment for vitiligo
研究组 & 干预措施
Control group
30 patients will apply the 5-Fluorouracil plain powder on the selected patch followed by 3 milliliters of water till complete dissolution of the powder.
干预措施: 5-Fluorouracil plain powder (Drug)
Study group
30 patients will apply a new effervescent mixture formula of 5-Fluorouracil prepared at faculty of pharmacy (Girls) - Al-Azhar university
干预措施: a new effervescent mixture 5-florouracil formula (Drug)
结局指标
主要结局
Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation
时间窗: 3 Months
repigmentation assessment
次要结局
未报告次要终点
研究者
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Al-Azhar University