T Central Memory Cells in Early Localized Non-Segmental Vitiligo

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05706636
• Other study ID #: V-1-23
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: September 2023

Study information

• Verified date: January 2023
• Source: Cairo University
• Contact: Rania Mogawer, MD
• Phone: 01068165330
• Email: raniamogawer[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• oral mini pulse
5mg / week oral dexamethasone
• Topical cream
topical fluticasone cream for body lesions and topical tacrolimus for face lesions

Device:
• targeted phototherapy
twice weekly targeted excimer light sessions

Locations

Country	Name	City	State
Egypt	Cairo university hospitals, dermatology outpatient clinic	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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