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NCT07742982

Overview

NCT ID: NCT07742982
Lead Sponsor: Aswan UniversityOTHER
Official Title: Efficacy of Topical Tyrosine Versus Topical 5-Fluorouracil With Fractional Erbium YAG Laser in Focal Vitiligo: A Randomised Clinical Trial
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

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Jun 1, 2026Actual
Primary Completion Date: Jun 1, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

- Patients with focal vitiligo

Exclusion Criteria:

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.

Study Plan

Study Type: Interventional
Phase: Early Phase 1
Enrollment: 40Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Yasmin Mahdy Mohamed Ahmed, MSCContact
yasmin17041133@aswu.edu.eg+201126607448

Similar Studies

Participant Group/Arms

Topical 5-Fluorouracil GroupActive 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 GroupActive 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