5-fluorouracil for Treatment of Stable Vitiligo

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06209138

Enrollment

Registered

2024-01-17

Start date

2024-01-23

Completion date

2024-04-15

Last updated

2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo

Keywords

5FU, Film forming gel, vitiligo, JAK3 gene expression, Dermabrasion

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.

Interventions

DRUG5 fluorouracil

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

OTHERSaline

Normal saline solution contains 0.9 percent sodium chloride (salt)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026