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Not Yet RecruitingNCT06946069

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
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATIONNB-UVB twice weeklyStandard phototherapy without additional systemic treatment.
OTHERNB-UVB + dexamethasone (2.5-3 mg/week)Combination therapy to enhance immunosuppression and repigmentation.

Timeline

Start date
2025-09-01
Primary completion
2025-12-30
Completion
2026-09-30
First posted
2025-04-27
Last updated
2025-04-27

Source: ClinicalTrials.gov record NCT06946069. Inclusion in this directory is not an endorsement.