Single Cell Genomics of Psoriatic Skin

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929745
• Other study ID #: 15-17769
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: December 9, 2020

Study information

• Verified date: September 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Procedure:
• Skin biopsy
Four 4-5 mm punch biopsies of the skin
• Blood draw
Blood will be drawn to test for HLA-cw6 status

Locations

Country	Name	City	State
United States	UCSF Psoriasis Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Janssen Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of immune cell population from skin biopsies		once
Secondary	Determination of diferentially expressed genes from skin biopsies		once
Secondary	Determination of HLA -cw6 status from blood samples		once