Single Cell Genomics of Psoriatic Skin

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02929745
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of California, San Francisco
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Wilson Liao, MD
Principal Investigator Affiliation University of California, San Francisco
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Arms & Interventions

Arms

Experimental: 10 HLA-Cw6+

HLA-Cw6+ patients will donate blood and skin samples

Experimental: 10 HLA Cw6-

HLA-Cw6- patients will donate blood and skin samples

Experimental: Healthy Skin

Healthy patients will donate blood and skin samples

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSF Psoriasis Center, San Francisco, California

Status

Recruiting

Address

UCSF Psoriasis Center

San Francisco, California, 94118

Site Contact

Quinn Thibodeaux, MD

[email protected]

415-944-7618

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