Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-24 @ 11:05 PM
NCT ID:
NCT06946069
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.
Study:
NCT06946069
Study Brief:
Protocol Section:
NCT06946069