Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

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Description

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.

Study Overview

Start Date
October 15, 2022
Completion Date
April 30, 2024
Enrollment
60
Date Posted
September 13, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Facualty of Pharmacy, Al Azhar University
Cairo 11765, Egypt

Eligibility

Minimum Age (years)
10
Maximum Age (years)
70
Eligibility Criteria
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 Contact Info

Study Contact Name
Neveen A. Kohaf, Ph.D
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05536856