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

NCT07742982 | Recruiting Early Phase 1 DMC

• 1 other identifier: Focal Vitiligo
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Focal Vitiligo

Outcome Measures

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) from baseline.

  1 year

Study Arms (2)

Topical 5-Fluorouracil Group

ACTIVE COMPARATOR

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

L-tyrosine Cream Group

ACTIVE COMPARATOR

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

Tyrosine DRUG

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

L-tyrosine Cream Group; Topical 5-Fluorouracil Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Patients with focal vitiligo

You may not qualify if:

• Pregnancy.
• Lactation.
• Patients with segmental vitiligo.
• Patients with autoimmune disease including thyroiditis.
• Patients with chronic systemic diseases,such as anemia ,diabetes mellitus, immunosuppression, or chronic infections.
• Patients with active skin infections.

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University Hospital

Aswān, Egypt

RECRUITING

MeSH Terms

Interventions

Tyrosine; Fluorouracil

Intervention Hierarchy (Ancestors)

Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Moustafa Adam Ali El Taieb, Professor

  Dermatology, Venereology and Andrology, Faculty of Medicine, Aswan University

  STUDY CHAIR

Central Study Contacts

Yasmin Mahdy Mohamed Ahmed, MSC

CONTACT

+201126607448; yasmin17041133@aswu.edu.eg

Moustafa Adam Ali El Taieb, professor

CONTACT

+201092991101; moustafa.eltaib@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Dermatology, Venereology and Andrology

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 10, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-06

Locations

EG (1)