T Central Memory Cells in Early Localized Non-Segmental Vitiligo

NCT ID: NCT05706636

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-04-15

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.

Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Early localized vitiligo on topical treatment

Cases will only receive topical steroids/ calcineurin inhibitors and targeted phototherapy

Group Type ACTIVE_COMPARATOR

Topical cream

Intervention Type DRUG

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

targeted phototherapy

Intervention Type DEVICE

twice weekly targeted excimer light sessions

Early localized vitiligo on topical and systemic treatment

Cases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy

Group Type ACTIVE_COMPARATOR

oral mini pulse

Intervention Type DRUG

5mg / week oral dexamethasone

Topical cream

Intervention Type DRUG

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

targeted phototherapy

Intervention Type DEVICE

twice weekly targeted excimer light sessions

Interventions

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oral mini pulse

5mg / week oral dexamethasone

Intervention Type DRUG

Topical cream

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

Intervention Type DRUG

targeted phototherapy

twice weekly targeted excimer light sessions

Intervention Type DEVICE

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Rania Mogawer

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samia Esmat, MD

Role: STUDY_CHAIR

Cairo University

Locations

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Cairo university hospitals, dermatology outpatient clinic

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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V-1-23

Identifier Type: -

Identifier Source: org_study_id

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