5-fluorouracil for Treatment of Stable Vitiligo

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06209138
• Other study ID #: HV04/2020
• Status: Completed
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

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

Other:
• Saline
Normal saline solution contains 0.9 percent sodium chloride (salt)

Locations

Country	Name	City	State
Egypt	Al-Azhar University	Assiut	No State

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Guartile grading scale	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
Primary	analysis of Jak3 expression in vitiligo lesions	the improvement will be associated with a reduction in JAK levels	2months