Tyrosine Vs Tacrolimus With NB-UVB in Vitiligo

NCT07532330 | Active Not Recruiting

• 1 other identifier: 1614/07/2025
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if adding topical tacrolimus or topical tyrosine to narrowband UVB phototherapy works to treat vitiligo in adults. It will also learn about the safety of both combinations. The main questions it aims to answer are: Which combination (UVB + tacrolimus or UVB + tyrosine) leads to greater skin repigmentation (color return) after 3 months of treatment? What side effects do participants experience with each combination? Researchers will compare three groups: UVB + tacrolimus, UVB + tyrosine, and UVB only to see which is more effective and safer. Participants will: Receive narrowband UVB phototherapy sessions two times per week at minimal erythema dose Apply either topical tacrolimus or topical tyrosine to their vitiligo patches twice daily Visit the clinic every one month for skin examination and photography Report any side effects or skin reactions

Conditions

Vitiligo

Keywords

vitiligo; phototherapy; narrowband UVB; tacrolimus; tyrosine

Outcome Measures

Primary Outcomes (1)

• Change in VESTA Score from Baseline to month 3

  The Vitiligo Extent Score by Target Area (VESTA) is a validated assessment tool that calculates the percentage of repigmentation within a target vitiligo patch. It accounts for both marginal and perifollicular repigmentation patterns. The score ranges from 0% (no repigmentation) to 100% (complete repigmentation). Higher scores indicate better treatment response.

  Baseline and after 3 months of treatment

Secondary Outcomes (2)

• Clinical Improvement grade

  after 3 months of treatment

• Incidence of Treatment-Related Adverse Events

  From baseline to month 3 (through study completion)

Study Arms (3)

topical tyrosine 2% + NB-UVB

EXPERIMENTAL

Narrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months.

Device: Narrowband UVB Phototherapy; Drug: Topical Tyrosine 2% cream

topical tacrolimus 0.1% + NB-UVB

EXPERIMENTAL

Narrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months.

Device: Narrowband UVB Phototherapy; Drug: Topical Tacrolimus 0.1% ointment

NB-UVB only

ACTIVE COMPARATOR

Narrowband UVB phototherapy twice weekly plus placebo vehicle cream applied twice daily for 3 months.

Device: Narrowband UVB Phototherapy

Interventions

Topical Tyrosine 2% cream DRUG

Topical tyrosine 2% cream applied twice daily to the designated vitiligo patch for 3 months. Each application consists of a thin layer covering the entire patch area.

topical tyrosine 2% + NB-UVB

Topical Tacrolimus 0.1% ointment DRUG

Topical tacrolimus 0.1% ointment applied twice daily to the designated vitiligo patch for 3 months. Each application consists of a thin layer covering the entire patch area.

topical tacrolimus 0.1% + NB-UVB

Narrowband UVB Phototherapy DEVICE

Narrowband ultraviolet B (UVB) phototherapy administered twice weekly at minimal erythema dose for 3 months. Each session delivers 311-312 nm wavelength radiation.

NB-UVB only; topical tacrolimus 0.1% + NB-UVB; topical tyrosine 2% + NB-UVB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65 years with vitiligo who are candidates for narrowband UVB (NB-UVB) phototherapy.

You may not qualify if:

• Pregnant or lactating women.
• Patients who have received any systemic or topical treatment for vitiligo within the preceding three months.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia Tertiary University Hospital, Faculty of Medicine, Minia University, Minia, Egypt.

Minya, Minya Governorate, 61519, Egypt

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Tacrolimus; Ointments; Tyrosine

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Almostafa M Ahmed

  Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology and Venereology

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: August 1, 2025
• Primary Completion: February 19, 2026
• Study Completion: April 10, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)