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NCT06946069 | NOT YET RECRUITING | Vitiligo

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

Assiut University

Information provided by (Responsible Party):

Alzahra Moahmed Mohamed Abdelhafez

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.

Condition or disease

Vitiligo

NB-UVB

Intervention/treatment

NB-UVB twice weekly

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

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Expression of CXCL11 & TEMRA in Serum of Vitiligo Patients Treated With Narrow-band UVB
Actual Study Start Date : 2025-09-01
Estimated Primary Completion Date : 2025-12-30
Estimated Study Completion Date : 2026-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Immunomodulatory Effects of NB-UVB and Steroids in Vitiligo: A Study on CXCL11 and TEMRA Biomarkers

Location Details

NCT06946069

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