Tyrosine Vs Tacrolimus With NB-UVB in Vitiligo

Comparative Efficacy of Topical Tacrolimus Versus Tyrosine as Co-Therapy to NB-UVB in Vitiligo: A Randomized Intra-Individual Controlled Clinical Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Device: Narrowband UVB Phototherapy; Drug: Topical Tyrosine 2% cream; Drug: Topical Tacrolimus 0.1% ointment

Detailed Description

Study Design and Setting:

This is a randomized, intra-individual (within-patient) controlled, open-label clinical trial conducted at the outpatient dermatology clinic of a university hospital in Egypt. The study duration is from August 2025 to February 2026. A total of 69 patients with vitiligo were enrolled, with 67 completing the study.

For each enrolled patient, three comparable vitiligo patches were identified on the patient's body. Each patch was randomly assigned to one of three treatment regimens, allowing each patient to serve as their own control.

Phototherapy Procedure:

Narrowband UVB (NB-UVB) phototherapy was administered to all patches simultaneously using a full-body cabinet. Treatment was given twice weekly for 3 months, starting at the minimal erythema dose (MED) with incremental increases of 10-20% per session based on erythema response. The same phototherapy protocol was applied uniformly to all three patches on each patient.

Topical Treatments:

For patches assigned to combination therapy, the topical agent (either tyrosine 2% cream or tacrolimus 0.1% ointment) was applied by the patient at home twice daily (morning and evening) every day. Patches were clearly marked to the patients, and patients received standardized written instructions. Compliance was monitored by asking about remaining quantity of topical preparation at each follow-up visit.

Blinding and Assessment:

Although the trial was open-label for patients and treating physicians, outcome assessors were two independent dermatologists blinded to treatment allocation. Standardized digital photographs were taken under consistent lighting conditions at baseline and at 3 months. For each photograph and repigmentation percentage was determined via VESTA score.

Safety Monitoring:

At each phototherapy session (twice weekly), patients were assessed for acute adverse effects including erythema, pain, and pruritus (yes or no). Any adverse event requiring treatment interruption or discontinuation was recorded.

Data Management:

All data were collected on paper case report forms and then entered into an electronic database (Microsoft Excel) by independent data entry operator. The final dataset was exported to SPSS for analysis.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya Governorate
    • Minya, Minya Governorate, Egypt, 61519
      • Minia Tertiary University Hospital, Faculty of Medicine, Minia University, Minia, Egypt.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: topical tyrosine 2% + NB-UVB; Narrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months.	Device: Narrowband UVB Phototherapy; Narrowband ultraviolet B (UVB) phototherapy administered twice weekly at minimal erythema dose for 3 months. Each session delivers 311-312 nm wavelength radiation.; Drug: Topical Tyrosine 2% cream; 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.
Experimental: topical tacrolimus 0.1% + NB-UVB; Narrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months.	Device: Narrowband UVB Phototherapy; Narrowband ultraviolet B (UVB) phototherapy administered twice weekly at minimal erythema dose for 3 months. Each session delivers 311-312 nm wavelength radiation.; Drug: Topical Tacrolimus 0.1% ointment; 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.
Active Comparator: NB-UVB only; Narrowband UVB phototherapy twice weekly plus placebo vehicle cream applied twice daily for 3 months.	Device: Narrowband UVB Phototherapy; Narrowband ultraviolet B (UVB) phototherapy administered twice weekly at minimal erythema dose for 3 months. Each session delivers 311-312 nm wavelength radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Improvement grade	Clinical improvement is categorized into four grades based on the percentage of repigmentation: Mild (<25% improvement), Moderate (25-50% improvement), Good (51-75% improvement), and Excellent (>75% improvement). Assessment is performed by two independent physicians using standardized photographs.	after 3 months of treatment
Incidence of Treatment-Related Adverse Events	Monitoring of local side effects including erythema, irritation, itching, and burning sensation at the application sites. Adverse events are recorded throughout the treatment period and graded for severity.	From baseline to month 3 (through study completion)

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Almostafa M Ahmed, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Actual): February 19, 2026
• Study Completion (Estimated): April 10, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: phototherapy; tyrosine; tacrolimus; vitiligo; narrowband UVB
• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo; Amino Acids, Peptides, and Proteins; Organic Chemicals; Pharmaceutical Preparations; Dosage Forms; Amino Acids; Macrolides; Lactones; Amino Acids, Aromatic; Amino Acids, Cyclic; Tacrolimus; Ointments; Tyrosine
• Other Study ID Numbers: 1614/07/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared because participants did not provide informed consent for data sharing beyond the primary study purpose, and the study is a single-center trial with a small sample size conducted in a routine clinical setting.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No