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Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo
Sponsor: Al-Azhar University
Summary
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.
Official title: Development and Clinical Evaluation of Topical 5-Fluorouracil Effervescent Powder Formulation in the Treatment of Vitiligo
Key Details
Gender
All
Age Range
10 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2022-10-15
Completion Date
2025-12-30
Last Updated
2026-01-06
Healthy Volunteers
No
Interventions
a new effervescent mixture 5-florouracil formula
30 patients will apply a new effervescent mixture 5-florouracil formula prepared at faculty of pharmacy (Girls) - Al-Azhar university
5-Fluorouracil plain powder
30 patients will apply the 5-florouracil plain powder on the selected patch followed by 3 milliliters of water till complete dissolution of the powder
Locations (1)
Facualty of Pharmacy, Al Azhar University
Cairo, Egypt