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Completed

NCT Number: NCT06209138

5-fluorouracil for Treatment of Stable Vitiligo

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.

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University

Asyut, No State, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5 fluorouracil

Drug

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

Saline

Other

Normal saline solution contains 0.9 percent sodium chloride (salt)

Primary outcomes

  1. Guartile grading scale

    Time frame: 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.

  2. analysis of Jak3 expression in vitiligo lesions

    Time frame: 2months

    the improvement will be associated with a reduction in JAK levels

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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