Single Cell Genomics of Psoriatic Skin

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Procedure: Skin biopsy; Procedure: Blood draw

• Registration Number: NCT02929745
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-11
• Primary Completion: 2020-12-09
• Study Completion: 2020-12-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
10 HLA Cw6-	Skin biopsy	HLA-Cw6- patients will donate blood and skin samples
10 HLA Cw6-	Blood draw	HLA-Cw6- patients will donate blood and skin samples
10 HLA-Cw6+	Blood draw	HLA-Cw6+ patients will donate blood and skin samples
Healthy Skin	Skin biopsy	Healthy patients will donate blood and skin samples
Healthy Skin	Blood draw	Healthy patients will donate blood and skin samples
10 HLA-Cw6+	Skin biopsy	HLA-Cw6+ patients will donate blood and skin samples

Primary Outcome Measures

Name	Time	Method
Determination of immune cell population from skin biopsies	once

Secondary Outcome Measures

Name	Time	Method
Determination of HLA -cw6 status from blood samples	once
Determination of diferentially expressed genes from skin biopsies	once

Trial Locations

Locations (1)

UCSF Psoriasis Center; 🇺🇸 San Francisco, California, United States