Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Phase 4

Recruiting

• Conditions: Vitiligo; Topical Fluorouracil; Effervescent Mixture
• Interventions: Drug: a new effervescent mixture 5-florouracil formula; Drug: 5-Fluorouracil plain powder

• Registration Number: NCT05536856
• Lead Sponsor: Al-Azhar University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-13
• Study Start: 2022-10-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	a new effervescent mixture 5-florouracil formula	30 patients will apply a new effervescent mixture formula of 5-Fluorouracil prepared at faculty of pharmacy (Girls) - Al-Azhar university
Control group	5-Fluorouracil plain powder	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.

Primary Outcome Measures

Name	Time	Method
Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation	3 Months	repigmentation assessment

Trial Locations

Locations (1)

Facualty of Pharmacy, Al Azhar University; 🇪🇬 Cairo, Egypt