Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

NCT ID: NCT05536856

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2025-12-30

Brief Summary

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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

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Conditions

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Vitiligo Topical Fluorouracil Effervescent Mixture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group

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.

Group Type EXPERIMENTAL

5-Fluorouracil plain powder

Intervention Type DRUG

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

Study group

30 patients will apply a new effervescent mixture formula of 5-Fluorouracil prepared at faculty of pharmacy (Girls) - Al-Azhar university

Group Type EXPERIMENTAL

a new effervescent mixture 5-florouracil formula

Intervention Type DRUG

30 patients will apply a new effervescent mixture 5-florouracil formula prepared at faculty of pharmacy (Girls) - Al-Azhar university

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Neveen Abd El Maksoad Kohaf

Lecturer of Clinical Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Facualty of Pharmacy, Al Azhar University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Neveen A. Kohaf, Ph.D

Role: CONTACT

+201069482380

Facility Contacts

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Neveen A. Kohaf, Ph.D

Role: primary

+201069482380

Other Identifiers

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35663/8/22

Identifier Type: -

Identifier Source: org_study_id

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