T Central Memory Cells in Early Localized Non-Segmental Vitiligo

Not Applicable

Completed

• Conditions: Vitiligo
• Interventions: Drug: oral mini pulse; Drug: Topical cream; Device: targeted phototherapy

• Registration Number: NCT05706636
• Lead Sponsor: Cairo University

Brief Summary

Assessing the level of circulating TCMs (cluster of differentiation (CD) 8+, CD3+,C- chemokine receptor (CCR)7, cluster of differentiation 45 receptor (CD45R) cells) in early localized vitiligo cases prior to treatment and after treatment in comparison to healthy controls. This, in turn, would provide insights regarding the role of TCMs in vitiligo and the role of early treatment in halting disease progression and autoimmune memory formation that accounts for high recurrence rate of vitiligo

Detailed Description

Assessing the level of circulating TCMs (CD8+ CD3+ CCR7+ CD45RO+ cells) in early localized vitiligo cases where samples will be processed and stained for CD8, CD3, CCR7, . CCR7, CD45R. Multi-parametric flow cytometry will be used to quantify CD3+ve, CD8+ve, CCR7+ve, CD45RO+ve TCM cells percentage, which will be expressed as a percentage from the total lymphocyte gate. This will be done prior to treatment and after treatment and will be compared to healthy controls.

Study Timeline

• Study First Submitted: 2023-01-21
• Study First Submitted QC: 2023-01-21
• Study First Posted: 2023-01-31
• Study Start: 2023-02-01
• Primary Completion: 2024-12-01
• Status Verified: 2025-04
• Study Completion: 2025-04-15
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Subjects with vitiligo localized to one anatomical area, of ≤ 6 months' duration

Exclusion Criteria

• Patients who received treatment of any type (topical or systemic) within the last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early localized vitiligo on topical and systemic treatment	Topical cream	Cases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy
Early localized vitiligo on topical and systemic treatment	targeted phototherapy	Cases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy
Early localized vitiligo on topical treatment	Topical cream	Cases will only receive topical steroids/ calcineurin inhibitors and targeted phototherapy
Early localized vitiligo on topical and systemic treatment	oral mini pulse	Cases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy
Early localized vitiligo on topical treatment	targeted phototherapy	Cases will only receive topical steroids/ calcineurin inhibitors and targeted phototherapy

Primary Outcome Measures

Name	Time	Method
comparing level of circulating central memory T cells (TCM) in early localized vitiligo cases to healthy controls	6 months	comparing TCM levels in early localized vitiligo cases prior to and after treatment to healthy controls
percent change in the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment	6 months	assessing the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment and calculating percent change in their levels
comparing percent change in the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment in those receiving systemic treatment to those receiving only topical treatment	6 months	assessing the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment and calculating percent change in their levels in those receiving systemic treatment to those receiving only topical treatment

Trial Locations

Locations (1)

Cairo university hospitals, dermatology outpatient clinic; 🇪🇬 Cairo, Egypt