T Central Memory Cells in Early Localized Non-Segmental Vitiligo

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: oral mini pulse
* Drug: Topical cream
* Device: targeted phototherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early localized vitiligo on topical treatment<br>Cases will only receive topical steroids/ calcineurin inhibitors and targeted phototherapy | Drug: Topical cream<br>* topical fluticasone cream for body lesions and topical tacrolimus for face lesions<br>Device: targeted phototherapy<br>* twice weekly targeted excimer light sessions<br>|
| Active Comparator: Early localized vitiligo on topical and systemic treatment<br>Cases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy | Drug: oral mini pulse<br>* 5mg / week oral dexamethasone<br>Drug: Topical cream<br>* topical fluticasone cream for body lesions and topical tacrolimus for face lesions<br>Device: targeted phototherapy<br>* twice weekly targeted excimer light sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparing level of circulating central memory T cells (TCM) in early localized vitiligo cases to healthy controls | comparing TCM levels in early localized vitiligo cases prior to and after treatment to healthy controls | 6 months | 
| percent change in the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment | assessing the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment and calculating percent change in their levels | 6 months | 
| 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 | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early localized vitiligo