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

A

Assiut University

Status

Not yet enrolling

Conditions

Vitiligo
NB-UVB

Treatments

Other: NB-UVB + dexamethasone (2.5-3 mg/week)
Radiation: NB-UVB twice weekly

Study type

Interventional

Funder types

Other

Identifiers

NCT06946069
Effects of NB-UVB and Steroids

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Group 1 (NB-UVB Monotherapy)
Experimental group
Description:
Standard phototherapy without additional systemic treatment.
Treatment:
Radiation: NB-UVB twice weekly
Group 2 (NB-UVB + OMP Steroids)
Experimental group
Description:
Combination therapy of NB-UVB + OMP Steroids to enhance immunosuppression and repigmentation.
Treatment:
Other: NB-UVB + dexamethasone (2.5-3 mg/week)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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