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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06946069
Enrollment
40
Registered
2025-04-27
Start date
2025-09-01
Completion date
2026-09-30
Last updated
2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NB-UVB, Vitiligo

Keywords

vitiligo, NB-UVB, CXCL11, TEMRA

Brief summary

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.

Detailed description

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.

Interventions

RADIATIONNB-UVB twice weekly

Standard phototherapy without additional systemic treatment.

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

Combination therapy to enhance immunosuppression and repigmentation.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a two-arm, parallel-group randomized controlled trial (RCT). Participants are randomly assigned (1:1 ratio) to one of two treatment arms: NB-UVB monotherapy (control group). NB-UVB + oral mini-pulse (OMP) steroids (intervention group). Both groups receive simultaneous but distinct interventions for direct comparison.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in serum CXCL11 & TEMRA levels6 monthsMeasured via ELISA before and after treatment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026