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

VITILIGO Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249064
• Other study ID #: IIBSP-VIT-2015-69
• Status: Completed
• Phase: N/A
• First received: August 10, 2017
• Last updated: August 21, 2017
• Start date: October 27, 2015
• Est. completion date: September 13, 2016

Study information

• Verified date: August 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 13, 2016
• Est. primary completion date: September 13, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient with vitiligo without treatment

Exclusion Criteria:

• Patient with inmunosupressive disease

• Patient receiving vitiligo treatment

Related Conditions & MeSH terms

• VITILIGO

Intervention

Diagnostic Test:
• CD 91 levels

• Tregs

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tregs levels		Baseline
Primary	Tregs levels		16 weeks
Secondary	LRP1 (CD91) levels		Baseline
Secondary	LRP1 (CD91) levels		16 weeks