PsoriasisNCT02929745
Single Cell Genomics of Psoriatic Skin
A study testing Skin biopsy and Blood draw in people with Psoriasis, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Skin biopsy and Blood draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 9 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For subjects in the psoriasis group:
- Ability to provide written consent and comply with the protocol
- At least 18 years of age
- Diagnosis of plaque psoriasis for at least 6 months prior to enrollment
- BSA > 5% and at least one target plaque on trunk or extremities greater than 10cm2
- For control subjects:
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- Ability to provide written consent and comply with the protocol
- At least 18 years of age
- No previous diagnosis of psoriasis or other inflammatory skin conditions
Who cannot join
- For subjects in the psoriasis group:
- Subject has non-plaque form of psoriasis.
- Subject has drug-induced psoriasis.
- Pregnancy at any point during the study period.
- Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
- Known HIV positive status.
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- Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
- Known coagulopathy.
- For control subjects:
- Any physical examination findings by the investigators consistent with psoriasis or other inflammatory skin conditions.
- Pregnancy at any point during the study period.
- Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
- Known HIV positive status.
- Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
- Known coagulopathy.
- Use of any immunosuppressant or immunomodulating therapies within 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Psoriasis Center
San Francisco, California, 94118
About this study
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
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.
- Conditions
- Psoriasis
- Being tested
- Skin biopsy, Blood draw
- Keywords
- immunology, genetics
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or surgery
Four 4-5 mm punch biopsies of the skin
Blood drawProcedure or surgery
Blood will be drawn to test for HLA-cw6 status
| Study group | Role | What they receive |
|---|---|---|
| 10 HLA-Cw6+ | Experimental | HLA-Cw6+ patients will donate blood and skin samples Receives: Procedure: Skin biopsy; Procedure: Blood draw |
| 10 HLA Cw6- | Experimental | HLA-Cw6- patients will donate blood and skin samples Receives: Procedure: Skin biopsy; Procedure: Blood draw |
| Healthy Skin | Experimental | Healthy patients will donate blood and skin samples Receives: Procedure: Skin biopsy; Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of immune cell population from skin biopsies
Measured: once
Secondary outcomes (2)
Determination of diferentially expressed genes from skin biopsies
Measured: once
Determination of HLA -cw6 status from blood samples
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study start1 Jul 2016
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Wilson Liao, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929745
- Sponsor's protocol ID
- 15-17769
- Status last verified
- Sep 2021
- First submitted
- 7 Oct 2016
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33309739
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02929745
- Acronym / sponsor ID
- 15-17769
- Conditions
- Psoriasis
- Keywords
- immunology, genetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 1 Jul 2016
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 HLA-Cw6+ | Experimental | Procedure: Skin biopsy, Procedure: Blood drawHLA-Cw6+ patients will donate blood and skin samples |
| 10 HLA Cw6- | Experimental | Procedure: Skin biopsy, Procedure: Blood drawHLA-Cw6- patients will donate blood and skin samples |
| Healthy Skin | Experimental | Procedure: Skin biopsy, Procedure: Blood drawHealthy patients will donate blood and skin samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to provide written consent and comply with the protocol
- At least 18 years of age
- Diagnosis of plaque psoriasis for at least 6 months prior to enrollment
- BSA > 5% and at least one target plaque on trunk or extremities greater than 10cm2
- Ability to provide written consent and comply with the protocol
Key exclusion criteria (16 listed)
- Subject has non-plaque form of psoriasis.
- Subject has drug-induced psoriasis.
- Pregnancy at any point during the study period.
- Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
- Known HIV positive status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsyFour 4-5 mm punch biopsies of the skin | Procedure or surgery | 10 HLA Cw6-, 10 HLA-Cw6+, Healthy Skin |
| Blood drawBlood will be drawn to test for HLA-cw6 status | Procedure or surgery | 10 HLA Cw6-, 10 HLA-Cw6+, Healthy Skin |
Primary outcome
Determination of immune cell population from skin biopsies
Time frame: once
2 secondary outcomes
Determination of diferentially expressed genes from skin biopsies
Time frame: once
Determination of HLA -cw6 status from blood samples
Time frame: once
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Background: PubMed 33309739Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilson Liao, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy and Blood draw in people with Psoriasis, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of immune cell population from skin biopsies (time frame: once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02929745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.