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RecruitingNCT07742982Updated Aug 11, 2026

Efficacy of Topical Tyrosine Versus Topical 5-Fluorouracil With Fractional Erbium YAG Laser

An Early Phase 1 interventional study of Tyrosine in Focal Vitiligo, sponsored by Aswan University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Aswan University · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Vitiligo is an autoimmune disorder affecting the skin, specifically targeting pigment-producing melanocytes, leading to noticeable regions of depigmentation characterized by white spots.

It is a widely prevalent skin disorder globally, affecting males and females almost equally, although it is reported slightly more frequently in females. In more than 60% of patients, the disease begins before the age of 30 and It has an estimated prevalence of roughly 0.2-2% across various populations, with around 0.4% in the European-derived white (EUR) population.

Read the detailed description

Vitiligo is an autoimmune disorder affecting the skin, specifically targeting pigment-producing melanocytes, leading to noticeable regions of depigmentation characterized by white spots. Two major clinical forms of vitiligo are recognized: non-segmental vitiligo, the most common type, usually presenting with symmetrical lesions, and segmental vitiligo, which manifests as unilateral depigmentation.

The exact pathogenesis of vitiligo remains unclear. However, it is believed to be a complex process involving genetic susceptibility, metabolic disturbances related to oxidative stress, impaired melanocyte adhesion to the epidermis, and immune mechanisms including both innate and adaptive immunity, ultimately leading to selective melanocyte destruction. Nevertheless, none of these mechanisms alone can completely explain melanocyte loss, suggesting that vitiligo is a multifactorial disorder.

The management of vitiligo aims to halt disease progression, stimulate repigmentation, and prevent relapse, with repigmentation largely driven by melanocyte stem cells in hair follicles that can migrate and restore functional melanocytes to depigmented areas.

Immune modulators, such as topical steroids, topical calcineurin inhibitiors, phototherapies, and systemic therapy like oral steroids, are the mainstay of traditional treatments. However, these options are still not ideal, which prompts research into novel vitiligo treatments. There is still a need for workable and well-tolerated therapeutic choices, even if treatment must be tailored to each patient and particular lesions.

5-Fluorouracil (5-FU) is a hydrophilic pyrimidine analogue with significant anticancer activity and limited water solubility, first discovered in the 1950s by Heidelberger through the introduction of a fluorine atom at the fifth position of the uracil molecule.

Topical (5-FU) was first reported as a treatment for vitiligo where it stimulates the proliferation of melanocytes within hair follicles that subsequently migrate to the epidermis and contribute to vmelanin production.

Tyrosine is a non-essential amino acid that is primarily obtained through dietary intake. It can also be synthesized from the essential amino acid phenylalanine through a hydroxylation reaction catalyzed by the enzyme phenylalanine hydroxylase . Although this enzyme is mainly expressed in the liver, it has also been detected in melanocytes.

Melanin synthesis, including both eumelanin and pheomelanin, begins with a common biochemical pathway. In this process, the amino acid tyrosine is initially converted to L-3,4-dihydroxyphenylalanine (L-DOPA) through the action of the enzyme tyrosine hydroxylase, which utilizes tetrahydrobiopterin as a cofactor. Subsequently, tyrosinase catalyzes the oxidation of L-DOPA to dopaquinone, a crucial intermediate in melanogenesis. From this stage, the pathway diverges toward the production of either eumelanin, which appears as a brown-black pigment, or pheomelanin, characterized by red-yellow coloration, depending on the cellular conditions and the availability of substrates.

An ablative fractional laser such as the 2940-nm erbium laser produces multiple microscopic beams that create microthermal zones within the skin. These micro-injuries induce controlled thermal damage that can lead to contraction of lesional tissue and stimulate the release of cytokines and growth factors, which promote melanocyte proliferation and migration. In addition, the temporary disruption of the skin barrier enhances the penetration of topical medications and ultraviolet light, thereby improving the therapeutic response.

02

Conditions studied

  • Focal Vitiligo

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03

In context

Vitiligo

343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.

This study's planned enrollment of 40 is above the median of 36 across 265 interventional studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

Aswan University is the lead sponsor of 47 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Patients with focal vitiligo

Exclusion criteria

Exclusion Criteria:

  • Pregnancy.
  • Lactation.
  • Patients with segmental vitiligo.
  • Patients with disease including thyroiditis.
  • Patients with chronic systemic diseases,such as anemia ,diabetes mellitus, , or chronic infections.
  • Patients with active skin infections.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Topical 5-Fluorouracil Group

    About 20 cases suffering from Focal Vitiligo will receive 6 sessions of fractional Er:YAG laser at two-week intervals. Starting \[immediately \] after each laser session, patients will apply topical 5-fluorouracil (5% cream) once daily for two weeks. This 14-day topical application cycle will be repeated following each of the 6 laser sessions.

    Drug: Tyrosine

  • Active comparator
    L-tyrosine Cream Group

    About 20 cases suffering from Focal Vitiligo will receive 6 sessions of fractional Er:YAG laser at two-week intervals. Starting \[immediately \] after each laser session, patients will apply topical L-tyrosine (2% cream) twice daily for two weeks. This continuous application will be maintained between laser sessions and after the final session.

    Drug: Tyrosine

Interventions

  • to evaluate and compare the therapeutic effects of topical tyrosine and topical( 5-FU) combined with fractional erbium:YAG laser in the treatment of focal vitiligo.

    Also known as: Topical 5-Fluorouracil

06

What researchers measure

Primary outcomes

  1. Treatment of Focal Vitiligo

    To measure the efficacy of the treatment by Topical Tyrosine and Topical 5-Fluorouracil With Fractional Erbium YAG Laser in repigmentation, assessed by the change in the Vitiligo Area Scoring Index (VASI ) which is determined by summing the products of the number of hand units and the percentage of depigmentation for each lesion, using predefined categories of 0%, 10%, 25%, 50%, 75%, 90%, and 100%. where as 0% is the worst and 100% is the best.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07742982
Lead sponsor
Aswan University
Responsible party
Yasmin Mahdy Mohamed (Resident of Dermatology, Venereology and Andrology, Aswan University) — Principal investigator
First posted
Aug 3, 2026
Start date
Jun 1, 2026
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 10, 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Yasmin Mahdy Mohamed Ahmed, MSC
Contact
yasmin17041133@aswu.edu.eg
+201126607448
Moustafa Adam Ali El Taieb, professor
Contact
moustafa.eltaib@aswu.edu.eg
+201092991101
Moustafa Adam Ali El Taieb, Professor
study chair · Dermatology, Venereology and Andrology, Faculty of Medicine, Aswan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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