5-fluorouracil for Treatment of Stable Vitiligo

Al-Azhar University

Status: Completed

Conditions: Vitiligo

Treatments: Drug: 5 fluorouracil; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06209138

HV04/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

CO2 laser assisted dermabrasion and 5FU film

Experimental group

Treatment:

Drug: 5 fluorouracil

CO2 laser assisted dermabrasion and saline

Active Comparator group

Treatment:

Other: Saline