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RECRUITING
NCT05536856
PHASE4

Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Sponsor: Al-Azhar University

View on ClinicalTrials.gov

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

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

Locations (1)

Facualty of Pharmacy, Al Azhar University

Cairo, Egypt