5-fluorouracil for Treatment of Stable Vitiligo

NCT ID: NCT06209138

Last Updated: 2024-04-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2024-04-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CO2 laser assisted dermabrasion and 5FU film

Group Type EXPERIMENTAL

5 fluorouracil

Intervention Type DRUG

5 fluorouracil (5FU) using different ratios of hydroxyl propyl methyl cellulose (HPMC) and Zein

CO2 laser assisted dermabrasion and saline

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type OTHER

Normal saline solution contains 0.9 percent sodium chloride (salt)

Interventions

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5 fluorouracil

5 fluorouracil (5FU) using different ratios of hydroxyl propyl methyl cellulose (HPMC) and Zein

Intervention Type DRUG

Saline

Normal saline solution contains 0.9 percent sodium chloride (salt)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud A Makki, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar University

Asyut, No State, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HV04/2020

Identifier Type: -

Identifier Source: org_study_id

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