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OpenTrials
Completed

NCT Number: NCT03249064

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with vitiligo without treatment

Exclusion criteria

  • Patient with inmunosupressive disease
  • Patient receiving vitiligo treatment

Treatment and study plan

CD 91 levels

Diagnostic Test

Tregs

Diagnostic Test

Primary outcomes

  1. Tregs levels

    Time frame: Baseline

  2. Tregs levels

    Time frame: 16 weeks

Secondary outcomes

  1. LRP1 (CD91) levels

    Time frame: Baseline

  2. LRP1 (CD91) levels

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 15, 2017
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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