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NCT Number: NCT06946069

Immunomodulatory Effects of NB-UVB and Steroids in Vitiligo: A Study on CXCL11 and TEMRA Biomarkers

this is a prospective, randomized controlled trial (RCT) investigating the immunological effects of narrowband UVB (NB-UVB) phototherapy-both as monotherapy and in combination with oral mini-pulse (OMP) steroids-in non-segmental vitiligo patients. The study evaluates changes in CXCL11 (a chemokine involved in T-cell recruitment) and TEMRA (terminally differentiated effector memory T cells re-expressing CD45RA) levels in serum before and after treatment.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Design:

Randomized controlled trial (RCT) with two parallel arms.

Duration: Six months (including baseline and follow-up assessments).

Setting: Outpatient dermatology clinic at Assiut University Hospital, Egypt.

Objectives:

Compare the immunomodulatory effects of NB-UVB alone vs. NB-UVB + OMP steroids in vitiligo patients.

Assess CXCL11 and TEMRA levels as potential biomarkers for disease activity and treatment response.

Evaluate clinical repigmentation using Vitiligo Extent Score (VES/VESplus).

Methodology:

40 patients with stable non-segmental vitiligo will be enrolled.

20 patients will undergo serum analysis for CXCL11 and TEMRA via ELISA.

Treatment arms:

NB-UVB monotherapy (twice weekly).

NB-UVB + OMP steroids (dexamethasone 2.5-3 mg/week).

Follow-up: Clinical and immunological assessments at baseline and 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinically diagnosed non-segmental vitiligo (stable for ≥3 months).

Fitzpatrick skin types III-V (common in the Egyptian population).

No recent systemic therapy for vitiligo (within the last 3 months).

Exclusion criteria

Photosensitivity disorders (e.g., lupus, porphyria).

Pregnancy or breastfeeding.

Active infections, malignancies, or immunosuppressive conditions.

History of hypertrophic scarring or melanoma.

Treatment and study plan

NB-UVB twice weekly

Radiation

Standard phototherapy without additional systemic treatment.

NB-UVB + dexamethasone (2.5-3 mg/week)

Other

Combination therapy to enhance immunosuppression and repigmentation.

Primary outcomes

  1. Change in serum CXCL11 & TEMRA levels

    Time frame: 6 months

    Measured via ELISA before and after treatment.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Expression of CXCL11 & TEMRA in Serum of Vitiligo Patients Treated With Narrow-band UVB

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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