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Taking peoplePhase 4

Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Key facts

Who runs it
Al-Azhar University
Where
Egypt1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
Phase
Phase 4
People taking part
60 people, planned
Started
15 Oct 2022
Planned end
30 Dec 2025
Type of study
Interventional, 2 groups
Treatments tested
  • a new effervescent mixture 5-florouracil formula
  • 5-Fluorouracil plain powder
Record updated
6 January 2026

Who can take part

Age
10 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Patients who will be diagnosed as localized stable vitiligo
  • Age older than 10 years
  • Stability of lesions for a duration of at least 1 year
  • Patients who didn't receive treatment for vitiligo in the previous 6 weeks before starting the study
  • Patients who agreed to join the study and signed written consent and continued till the end of the follow up period

Who cannot take part

  • Patients receiving any systemic or topical treatment for vitiligo
  • Other uncontrolled systemic illnesses
  • Patients with vitiligo patches on mucous membrane,
  • Patients with Koebner phenomenon,

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 10 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Control groupTreatment being tested

    30 patients will apply the 5-Fluorouracil plain powder on the selected patch followed by 3 milliliters of water till complete dissolution of the powder.

    Treatment: 5-Fluorouracil plain powder

  • Study groupTreatment being tested

    30 patients will apply a new effervescent mixture formula of 5-Fluorouracil prepared at faculty of pharmacy (Girls) - Al-Azhar university

    Treatment: a new effervescent mixture 5-florouracil formula

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Development and Clinical Evaluation of Topical 5-Fluorouracil Effervescent Powder Formulation in the Treatment of Vitiligo
Fit questions
Built from NCT05536856, who can take part
Record updated
6 January 2026