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NCT Number: NCT02929745

Single Cell Genomics of Psoriatic Skin

The purpose of this study is to understand how genetics play a role in psoriasis. Specifically, a genetic allele HLA-Cw6 is known to be associated with psoriasis, and this study aims to find out how it affects genetic and protein expression in patients with psoriasis, compared to healthy people, at a single-cell level using a novel flow cytometry and RNA-sequencing protocol.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Psoriasis Center

San Francisco, California, 94118, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For subjects in the psoriasis group:

  • Ability to provide written consent and comply with the protocol
  • At least 18 years of age
  • Diagnosis of plaque psoriasis for at least 6 months prior to enrollment
  • BSA > 5% and at least one target plaque on trunk or extremities greater than 10cm2

For control subjects:

  • Ability to provide written consent and comply with the protocol
  • At least 18 years of age
  • No previous diagnosis of psoriasis or other inflammatory skin conditions

Exclusion criteria

For subjects in the psoriasis group:

  • Subject has non-plaque form of psoriasis.
  • Subject has drug-induced psoriasis.
  • Pregnancy at any point during the study period.
  • Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
  • Known HIV positive status.
  • Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
  • Known coagulopathy.

For control subjects:

  • Any physical examination findings by the investigators consistent with psoriasis or other inflammatory skin conditions.
  • Pregnancy at any point during the study period.
  • Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
  • Known HIV positive status.
  • Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
  • Known coagulopathy.
  • Use of any immunosuppressant or immunomodulating therapies within 6 months.

Treatment and study plan

skin biopsy

Procedure

Four 4-5 mm punch biopsies of the skin

Blood draw

Procedure

Blood will be drawn to test for HLA-cw6 status

Primary outcomes

  1. Determination of immune cell population from skin biopsies

    Time frame: once

Secondary outcomes

  1. Determination of diferentially expressed genes from skin biopsies

    Time frame: once

  2. Determination of HLA -cw6 status from blood samples

    Time frame: once

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Janssen Pharmaceuticals

Registry information

Official study title

Elucidating the Fundamental Differences Between HLA-Cw6 Positive and HLA-Cw6 Negative Psoriasis Skin Lesions, With a Comparison to Healthy Skin, at the Single Cell Level of the Infiltrated Immune Cell Types

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 11, 2016
Registry last updated
Sep 23, 2021

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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