Single Cell Genomics of Psoriatic Skin

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT02929745
• Collaborator: Janssen Pharmaceuticals (Industry)
• Enrollment: 16
• Location: 1
• Arms: 3
• Duration (Months): 53.3
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Procedure: Skin biopsy; Procedure: Blood draw	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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 Start Date: Jul 1, 2016
• Actual Primary Completion Date: Dec 9, 2020
• Actual Study Completion Date: Dec 9, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Determination of immune cell population from skin biopsies [once]

Secondary Outcome Measures

1. Determination of diferentially expressed genes from skin biopsies [once]

2. Determination of HLA -cw6 status from blood samples [once]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Psoriasis Center	San Francisco	California	United States	94118

Sponsors and Collaborators

• University of California, San Francisco
• Janssen Pharmaceuticals

Investigators

• Principal Investigator: Wilson Liao, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02929745
• Other Study ID Numbers: 15-17769
• First Posted: Oct 11, 2016
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by University of California, San Francisco: immunology, genetics
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Sep 23, 2021