Clinical Trial

Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Recruiting Phase 4
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2022-09-12; most recent amendment 2026-01-04.
Status change: Not Yet Recruiting → Recruiting 2022-11-15
Trial Details
NCT Number NCT05536856
Lead Sponsor Al-Azhar University
Conditions Vitiligo, Topical Fluorouracil, Effervescent Mixture
Enrollment 60 participants
Start Date 2022-10-15
Primary Completion 2025-12-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-06