Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Last updated: July 30, 2024
Sponsor: Al-Azhar University
Overall Status: Active - Recruiting

Phase

4

Condition

Vitiligo

Treatment

5-Fluorouracil plain powder

a new effervescent mixture 5-florouracil formula

Clinical Study ID

NCT05536856
35663/8/22
  • Ages 10-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 beforestarting the study.

  • Patients who agreed to join the study and signed written consent and continued tillthe end of the follow up period

Exclusion

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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: 5-Fluorouracil plain powder
Phase: 4
Study Start date:
October 15, 2022
Estimated Completion Date:
October 30, 2024

Connect with a study center

  • Facualty of Pharmacy, Al Azhar University

    Cairo, 11765
    Egypt

    Active - Recruiting

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