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Completed

NCT Number: NCT05706636

T Central Memory Cells in Early Localized Non-Segmental Vitiligo

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

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university hospitals, dermatology outpatient clinic

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral mini pulse

Drug

5mg / week oral dexamethasone

Topical Cream

Drug

topical fluticasone cream for body lesions and topical tacrolimus for face lesions

targeted phototherapy

Device

twice weekly targeted excimer light sessions

Primary outcomes

  1. comparing level of circulating central memory T cells (TCM) in early localized vitiligo cases to healthy controls

    Time frame: 6 months

    comparing TCM levels in early localized vitiligo cases prior to and after treatment to healthy controls

  2. percent change in the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment

    Time frame: 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

  3. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

T Central Memory Cells in Early Localized Non-Segmental Vitiligo and the Effect of Treatment

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 31, 2023
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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