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NCT Number: NCT05536856

Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

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.

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Key information

Conditions

Vitiligo Effervescent Mixture Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Topical Fluorouracil

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Facualty of Pharmacy, Al Azhar University

Cairo, 11765, Egypt

Location status: Recruiting

Location contact

Neveen A. Kohaf, Ph.D

CONTACT

[email protected]

+201069482380

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

a new effervescent mixture 5-florouracil formula

Drug

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

5-Fluorouracil plain powder

Drug

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

Primary outcomes

  1. Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation

    Time frame: 3 Months

    repigmentation assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Neveen A. Kohaf, Ph.D

CONTACT

[email protected]

+201069482380

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2022
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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