Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536856
• Other study ID #: 35663/8/22
• Status: Recruiting
• Phase: Phase 4
• Start date: October 15, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Al-Azhar University
• Contact: Neveen A. Kohaf, Ph.D
• Phone: +201069482380
• Email: nevenabdo[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• a new effervescent mixture 5-florouracil formula
30 patients will apply a new effervescent mixture 5-florouracil formula prepared at faculty of pharmacy (Girls) - Al-Azhar university
• 5-Fluorouracil plain powder
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

Locations

Country	Name	City	State
Egypt	Facualty of Pharmacy, Al Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation	repigmentation assessment	3 Months