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

NCT ID: NCT06946069

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Vitiligo NB-UVB

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 (NB-UVB Monotherapy)

Standard phototherapy without additional systemic treatment.

Group Type EXPERIMENTAL

NB-UVB twice weekly

Intervention Type RADIATION

Standard phototherapy without additional systemic treatment.

Group 2 (NB-UVB + OMP Steroids)

Combination therapy of NB-UVB + OMP Steroids to enhance immunosuppression and repigmentation.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Combination therapy to enhance immunosuppression and repigmentation.

Interventions

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NB-UVB twice weekly

Standard phototherapy without additional systemic treatment.

Intervention Type RADIATION

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

Combination therapy to enhance immunosuppression and repigmentation.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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ALZAHRA MOAHMED MOHAMED ABDELHAFEZ

resident at the dermatology Surgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Effects of NB-UVB and Steroids

Identifier Type: -

Identifier Source: org_study_id

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