Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-25 @ 8:36 PM
Study NCT ID:
NCT06946069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunomodulatory Effects of NB-UVB and Steroids in Vitiligo: A Study on CXCL11 and TEMRA Biomarkers
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Expression of CXCL11 & TEMRA in Serum of Vitiligo Patients Treated With Narrow-band UVB
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: