Single Cell Genomics of Psoriatic Skin

September 17, 2021 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94118
        • UCSF Psoriasis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

For subjects in the psoriasis group:

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

For control subjects:

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

Exclusion Criteria:

For subjects in the psoriasis group:

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

For control subjects:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 HLA-Cw6+
HLA-Cw6+ patients will donate blood and skin samples
Procedure: Skin biopsy
Four 4-5 mm punch biopsies of the skin
Procedure: Blood draw
Blood will be drawn to test for HLA-cw6 status
Experimental: 10 HLA Cw6-
HLA-Cw6- patients will donate blood and skin samples
Procedure: Skin biopsy
Four 4-5 mm punch biopsies of the skin
Procedure: Blood draw
Blood will be drawn to test for HLA-cw6 status
Experimental: Healthy Skin
Healthy patients will donate blood and skin samples
Procedure: Skin biopsy
Four 4-5 mm punch biopsies of the skin
Procedure: Blood draw
Blood will be drawn to test for HLA-cw6 status

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of immune cell population from skin biopsies
Time Frame: once
once

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of diferentially expressed genes from skin biopsies
Time Frame: once
once
Determination of HLA -cw6 status from blood samples
Time Frame: once
once

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Janssen Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

December 9, 2020

Study Completion (Actual)

December 9, 2020

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-17769

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe