An interventional study of Narrowband UVB Phototherapy and Topical Tacrolimus 0.1% ointment in Vitiligo, sponsored by Minia University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Minia University · Not applicable, Interventional, and Treatment
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 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.
298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.
This study's enrollment of 67 is above the median of 30 across 227 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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 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.
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.
Time frame: Baseline and after 3 months of treatment
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.
Time frame: 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.
Time frame: From baseline to month 3 (through study completion)
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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