NCT02929745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2020

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

4.4 years

First QC Date

October 7, 2016

Last Update Submit

September 17, 2021

Conditions

Psoriasis

Keywords

immunology, genetics

Outcome Measures

Primary Outcomes (1)

  • Determination of immune cell population from skin biopsies

    once

Secondary Outcomes (2)

  • Determination of diferentially expressed genes from skin biopsies

    once

  • Determination of HLA -cw6 status from blood samples

    once

Study Arms (3)

10 HLA-Cw6+

EXPERIMENTAL

HLA-Cw6+ patients will donate blood and skin samples

Procedure: Skin biopsyProcedure: Blood draw

10 HLA Cw6-

EXPERIMENTAL

HLA-Cw6- patients will donate blood and skin samples

Procedure: Skin biopsyProcedure: Blood draw

Healthy Skin

EXPERIMENTAL

Healthy patients will donate blood and skin samples

Procedure: Skin biopsyProcedure: Blood draw

Interventions

Skin biopsyPROCEDURE

Four 4-5 mm punch biopsies of the skin

10 HLA Cw6-10 HLA-Cw6+Healthy Skin
Blood drawPROCEDURE

Blood will be drawn to test for HLA-cw6 status

10 HLA Cw6-10 HLA-Cw6+Healthy Skin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Psoriasis Center

San Francisco, California, 94118, United States

Location

Related Publications (1)

  • 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.

    PMID: 33309739BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Wilson Liao, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 11, 2016

Study Start

July 1, 2016

Primary Completion

December 9, 2020

Study Completion

December 9, 2020

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

US(1)