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Single Cell Genomics of Psoriatic Skin

Primary Purpose

Psoriasis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Skin biopsy

Blood draw

About this trial

This is an interventional basic science trial for Psoriasis focused on measuring immunology, genetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

UCSF Psoriasis Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

10 HLA-Cw6+

10 HLA Cw6-

Healthy Skin

Arm Description

HLA-Cw6+ patients will donate blood and skin samples

HLA-Cw6- patients will donate blood and skin samples

Healthy patients will donate blood and skin samples

Outcomes

Primary Outcome Measures

Determination of immune cell population from skin biopsies

Secondary Outcome Measures

Determination of diferentially expressed genes from skin biopsies

Determination of HLA -cw6 status from blood samples

Full Information

NCT ID

NCT02929745

First Posted

October 7, 2016

Last Updated

September 17, 2021

Sponsor

University of California, San Francisco

Collaborators

Janssen Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02929745

Brief Title

Single Cell Genomics of Psoriatic Skin

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

July 1, 2016 (undefined)

Primary Completion Date

December 9, 2020 (Actual)

Study Completion Date

December 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

Janssen Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

immunology, genetics

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10 HLA-Cw6+

Arm Type

Experimental

Arm Description

HLA-Cw6+ patients will donate blood and skin samples

Arm Title

10 HLA Cw6-

Arm Type

Experimental

Arm Description

HLA-Cw6- patients will donate blood and skin samples

Arm Title

Healthy Skin

Arm Type

Experimental

Arm Description

Healthy patients will donate blood and skin samples

Intervention Type

Procedure

Intervention Name(s)

Skin biopsy

Intervention Description

Four 4-5 mm punch biopsies of the skin

Intervention Type

Procedure

Intervention Name(s)

Blood draw

Intervention Description

Blood will be drawn to test for HLA-cw6 status

Primary Outcome Measure Information:

Title

Determination of immune cell population from skin biopsies

Time Frame

once

Secondary Outcome Measure Information:

Title

Determination of diferentially expressed genes from skin biopsies

Time Frame

once

Title

Determination of HLA -cw6 status from blood samples

Time Frame

once

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilson Liao, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSF Psoriasis Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94118

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33309739

Citation

Liu J, Chang HW, Huang ZM, Nakamura M, Sekhon S, Ahn R, Munoz-Sandoval P, Bhattarai S, Beck KM, Sanchez IM, Yang E, Pauli M, Arron ST, Fung-Leung WP, Munoz E, Liu X, Bhutani T, North J, Fourie AM, Rosenblum MD, Liao W. Single-cell RNA sequencing of psoriatic skin identifies pathogenic Tc17 cell subsets and reveals distinctions between CD8+ T cells in autoimmunity and cancer. J Allergy Clin Immunol. 2021 Jun;147(6):2370-2380. doi: 10.1016/j.jaci.2020.11.028. Epub 2020 Dec 9.

Results Reference

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Single Cell Genomics of Psoriatic Skin

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