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Single Cell Genomics of Psoriatic Skin

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ClinicalTrials.gov Identifier: NCT02929745
Recruitment Status : Recruiting
First Posted : October 11, 2016
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psoriasis Procedure: Skin biopsy Procedure: Blood draw Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 : July 1, 2016
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Psoriasis

Arm Intervention/treatment
Experimental: psoriasis group
10 HLA-Cw6+ and 10 HLA Cw6- psoriasis patients will undergo skin biopsy once.
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 control group
10 healthy patients will undergo skin biopsy once.
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




Primary Outcome Measures :
  1. Determination of immune cell population from skin biopsies [ Time Frame: once ]

Secondary Outcome Measures :
  1. Determination of diferentially expressed genes from skin biopsies [ Time Frame: once ]
  2. Determination of HLA -cw6 status from blood samples [ Time Frame: once ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929745


Contacts
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Contact: Quinn Thibodeaux, MD 415-944-7618 psoriasis@ucsf.edu

Locations
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United States, California
UCSF Psoriasis Center Recruiting
San Francisco, California, United States, 94118
Contact: Quinn Thibodeaux, MD    415-944-7618    psoriasis@ucsf.edu   
Principal Investigator: Wilson Liao, MD         
Sponsors and Collaborators
University of California, San Francisco
Janssen Pharmaceuticals
Investigators
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Principal Investigator: Wilson Liao, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02929745     History of Changes
Other Study ID Numbers: 15-17769
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Keywords provided by University of California, San Francisco:
immunology, genetics

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases