5-fluorouracil for Treatment of Stable Vitiligo

April 15, 2024 updated by: Mahmoud A Makki, MD, Al-Azhar University

Tailoring of HPMC-Zein Based Film Forming Gel of 5-fluorouracil for Treat-ment of Stable Vitiligo: a Strategy Assisted by Carbon Dioxide Laser Dermabra-sion

Vitiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vtiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal. 5FU is a well-known chemotherapeutic agent that has been used for colorectal cancer treatment. The drug prevents DNA synthesis by inhibiting the thymidylate synthetase. The hyperpigmenta-tion of the skin is the most side effect observed with 5-FU therapy which directed its use in treat-ment of vitiligo. Besides, many studies reported that 5-FU could induce regimentation in vitiligo by direct stimulation of melanocytes and increasing melanosomes numbers in the keratinocytes.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • No State
      • Assiut, No State, Egypt
        • Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with stable vitlligo

Exclusion Criteria:

  • patients under the age of 10 years.
  • Individuals with a history of the Koebner phenomenon, a tendency for keloid or hypertrophic scarring
  • Pregnancy.
  • Recent isotretinoin therapy within the last 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CO2 laser assisted dermabrasion and 5FU film
Drug: 5 fluorouracil
5 fluorouracil (5FU) using different ratios of hydroxyl propyl methyl cellulose (HPMC) and Zein
Active Comparator: CO2 laser assisted dermabrasion and saline
Other: Saline
Normal saline solution contains 0.9 percent sodium chloride (salt)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Guartile grading scale
Time Frame: 2 months
A grading system with a quartile grading scale was used. Here, grading of > 75% will be considered excellent improvement, very good (51-75%), good (50-25%), poor (<25%), mild (25%), and poor improvement if less than 25% grading.
2 months
analysis of Jak3 expression in vitiligo lesions
Time Frame: 2months
the improvement will be associated with a reduction in JAK levels
2months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Actual)

April 15, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

January 14, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HV04/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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