5-fluorouracil for Treatment of Stable Vitiligo

Not Applicable

Completed

• Conditions: Vitiligo
• Interventions: Other: Saline; Drug: 5 fluorouracil

• Registration Number: NCT06209138
• Lead Sponsor: Al-Azhar University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2024-01-14
• Study First Posted: 2024-01-17
• Study Start: 2024-01-23
• Status Verified: 2024-04
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CO2 laser assisted dermabrasion and saline	Saline	-
CO2 laser assisted dermabrasion and 5FU film	5 fluorouracil	-

Primary Outcome Measures

Name	Time	Method
Guartile grading scale	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.
analysis of Jak3 expression in vitiligo lesions	2months	the improvement will be associated with a reduction in JAK levels

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Assiut, No State, Egypt