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Single Cell Genomics of Psoriatic Skin

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02929745
Enrollment
16
Registered
2016-10-11
Start date
2016-07-01
Completion date
2020-12-09
Last updated
2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

immunology, genetics

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.

Interventions

PROCEDURESkin biopsy

Four 4-5 mm punch biopsies of the skin

PROCEDUREBlood draw

Blood will be drawn to test for HLA-cw6 status

Sponsors

Janssen Pharmaceuticals
CollaboratorINDUSTRY
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Determination of immune cell population from skin biopsiesonce

Secondary

MeasureTime frame
Determination of diferentially expressed genes from skin biopsiesonce
Determination of HLA -cw6 status from blood samplesonce

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026