Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249064
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
VITILIGO Diagnostic Test: CD 91 levels Diagnostic Test: Tregs

Layout table for study information
Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo
Actual Study Start Date : October 27, 2015
Actual Primary Completion Date : September 13, 2016
Actual Study Completion Date : September 13, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Group/Cohort Intervention/treatment
Vitiligo untreated patients Diagnostic Test: CD 91 levels
Diagnostic Test: Tregs
Control. Patients without vitiligo Diagnostic Test: CD 91 levels
Diagnostic Test: Tregs



Primary Outcome Measures :
  1. Tregs levels [ Time Frame: Baseline ]
  2. Tregs levels [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. LRP1 (CD91) levels [ Time Frame: Baseline ]
  2. LRP1 (CD91) levels [ Time Frame: 16 weeks ]

Biospecimen Retention:   Samples Without DNA
Periferic blood /serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
18 to 65 years-old both sex
Criteria

Inclusion Criteria:

- Patient with vitiligo without treatment

Exclusion Criteria:

  • Patient with inmunosupressive disease
  • Patient receiving vitiligo treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249064


Locations
Layout table for location information
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Layout table for additonal information
Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03249064    
Other Study ID Numbers: IIBSP-VIT-2015-69
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
TREGS
CD91
LRP1
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases