Resident Memory T Cells in Vitiligo

Vitiligo Clinical Trial

Official title:

Tissue Resident Memory T Cells in Early & Late Cases of Generalized Non-segmental Vitiligo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05223738
• Other study ID #: TRMvit
• Status: Active, not recruiting
• Start date: December 31, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2022
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to detect the presence and diversity of Tissue resident memory T cell populations in early and late cases of generalized non-segmental Vitiligo.

Description:

• Written informed consent obtained from every participant.

• Detailed history taking including onset, course, duration of the disease, aggravating factors and received medications

• VASI score assessed in every patient.

• Patients photographed, divided into two groups early & late cases and 3 mm punch biopsies will be taken from perilesional and non lesional skin.

• Biopsies processed and stained for CD8 & CD69 in cases of early group, & late group and controls by immunofluorescence.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: February 1, 2022
• Est. primary completion date: March 30, 2021
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• - Patients with Generalized non-segmental Vitiligo ( lesions in more than one anatomical site ).

• Both genders.

• Early group: onset less than or equal 6 months.

• Late group: onset more than 6 months

Exclusion Criteria:

• Localized or Segmental Vitiligo.

• Age < 14 years.

• Pregnant females

• Patient who received treatment of any type within the last 3 months for the late group.

• Patients with other skin diseases or immunosuppression

Related Conditions & MeSH terms

• Vitiligo

Locations

Country	Name	City	State
Egypt	Kasr El Ainy University hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD8+ immunofluorescence	Number of Tissue resident Memory cells by positively stained by CD8+ in early and late generalized non segmental vitiligo patients	6months-1 year
Primary	CD69+ immunofluorescence	Number of Tissue resident Memory cells by positively stained by CD8+ in early and late generalized non segmental vitiligo patients	6months-1 year
Primary	Double CD8+ and CD69+ immunofluorescence	Number of Tissue resident Memory cells by double stained by CD8+ &CD 69+ in early and late generalized non segmental vitiligo patients	6months-1 year
Primary	VASI	Vitiligo Area and Severity index minimum 0 maximum 100, the larger the number the worse the condition	6months-1 year