Tyrosine Vs Tacrolimus With NB-UVB in Vitiligo

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.

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.