Clinical trial NCT02929745: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: immunology, genetics
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceuticals
First posted: 2016-10-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determination of immune cell population from skin biopsies
timeFrame: once
Secondary outcomes:
measure: Determination of diferentially expressed genes from skin biopsies
timeFrame: once
measure: Determination of HLA -cw6 status from blood samples
timeFrame: once
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Psoriasis Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Wilson Liao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.