Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo

Completed

• Conditions: VITILIGO
• Interventions: Diagnostic Test: CD 91 levels; Diagnostic Test: Tregs

• Registration Number: NCT03249064
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

This study aims to evaluate some differences in the immune system between patients with vitiligo and patients without the disease.

These differences will be evaluated by the extraction of peripheral blood that will be analyzed before the treatment and after the treatment that, in the habitual way and at the discretion of the responsible dermatologist.

Patients agreeing to participate in the study will be subjected to extraction of two tubes (20 ml) of peripheral blood (baseline) and after 12 weeks (+/- 5 days) of treatment.

Therefore, neither treatment nor follow-up visits will be modified by participation, but will be the same whether or not participate in the study.

In the case of controls, two peripheral blood tubes (20ml) will be removed in a single participation.

Patients with vitiligo will also be asked to complete questionnaires to measure stress, depression and perception of disease (PSS-10, Skindex-29, HADS, Likert) before and after 12 weeks (+/- 5 days) of therapeutic intervention .

This study will include 20 patients with active non-segmental vitiligo and 10 controls without the disease. The duration of participation in this study will be 12 weeks (+/- 5 days) for patients with vitiligo and a single participation (extraction of 20 ml of peripheral venous blood) for the controls.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-27
• Primary Completion: 2016-09-13
• Study Completion: 2016-09-13
• Status Verified: 2017-08
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-15
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patient with vitiligo without treatment

Exclusion Criteria

• Patient with inmunosupressive disease
• Patient receiving vitiligo treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control. Patients without vitiligo	Tregs	-
Vitiligo untreated patients	Tregs	-
Control. Patients without vitiligo	CD 91 levels	-
Vitiligo untreated patients	CD 91 levels	-

Primary Outcome Measures

Name	Time	Method
Tregs levels	16 weeks

Secondary Outcome Measures

Name	Time	Method
LRP1 (CD91) levels	16 weeks

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain