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Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

RecruitingPhase 4Ages 10 Years - 70 YearsAllAl-Azhar University
NCT05536856 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • a new effervescent mixture 5-florouracil formula
  • 5-Fluorouracil plain powder
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Where

1 site
Facualty of Pharmacy, Al Azhar University
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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