Actively Recruiting

Phase 4
Age: 10Years - 70Years
All Genders
NCT05536856

Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Led by Al-Azhar University · Updated on 2026-01-06

60

Participants Needed

1

Research Sites

167 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Who Can Participate

Age: 10Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with localized stable vitiligo
  • Age older than 10 years
  • Vitiligo lesions stable for at least 1 year
  • No vitiligo treatment received in the 6 weeks before starting the study
  • Agreed to join the study, signed written consent, and committed to follow-up
Not Eligible

You will not qualify if you...

  • Vitiligo patches on mucous membranes
  • Presence of Koebner phenomenon
  • Uncontrolled systemic illnesses
  • Currently receiving systemic or topical treatment for vitiligo

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Facualty of Pharmacy, Al Azhar University

Cairo, Egypt, 11765

Actively Recruiting

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Research Team

N

Neveen A. Kohaf, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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