NCT05536856

Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Development and Clinical Evaluation of Topical 5-Fluorouracil Effervescent Powder Formulation in the Treatment of Vitiligo

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 10 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitiligo
• Topical Fluorouracil
• Effervescent Mixture

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2022-10-15
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2022-09-13
• Last updated: 2026-01-06

Locations

1 site across 1 country: Egypt