PsoriasisNCT03302390
Role of Chemokine and Chemokine Receptor in Psoriasis
An observational study of Psoriasis, run by University of California, Davis at 1 site in United States.
Trial summary
This study aims to elucidate the role of Chemokine and chemokine receptor in the pathogenesis of Psoriasis by using human psoriasis skin xenograft SCID mouse model. The hypothesis is that chemokine and chemokine receptor play important roles in psoriasis and establishment of human skin xenograft mouse model provide… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Shave Biopsy of Psoriasis Lesion
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2017to 13 Apr 2018
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects 18 years of age or greater will be recruited for this study. The study population will include patients at UC Davis Dermatology with diagnostic evidence for psoriasis who do not have coexisting inflammatory diseases.
Who may be able to join
- Subjects 18 years of age or greater
- Subjects need to fulfill the diagnostic evidence of psoriasis with or without psoriatic arthritis
- Subject may take the following medicines: NSAID, hydroxychloroquine, sulfasalazine, prednisone (<10 mg/day), Methotrexate (10 mg/week)
- Subject needs to stop topical skin preparations other than emollients in one small plaque of psoriasis for 3-4 wks from where the shave biopsy will be taken
- Willing and able to provide informed consent in English
Who cannot join
- Subjects less than 18 years old
- no clinical evidence of psoriatic skin
- Subjects with contraindications for biopsy, and patients receiving anticoagulants
- Subjects with active hepatitis B or Hepatitis C infection
- Subjects with concomitant inflammatory diseases such as inflammatory bowel disease, gout
- Subjects who are taking the following systemic biological therapies for psoriasis: cyclosporine, methotrexate, prednisone, acitretin, sulfasalazine, certolizumab, etanercept, adalimumab, infliximab, golimumab, secukinumab, ustekinumab, and apremilast. Other systemic medications may exclude the subject from the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to elucidate the role of Chemokine and chemokine receptor in the pathogenesis of Psoriasis by using human psoriasis skin xenograft SCID mouse model. The hypothesis is that chemokine and chemokine receptor play important roles in psoriasis and establishment of human skin xenograft mouse model provide excellent platform to test the hypothesis.
Read the detailed description
Chemokines belongs to a large group of small chemotactic proteins (8-11 kilodaltons in size). Upon engagement of chemokine, chemokine receptor can activate downstream intracellular signaling pathways and results in diverse cellular processing such as cytoskeleton reorganization and cell locomotion. Chemokines are chemoattractant factors and can stimulate directional migration of all classes of leukocytes such as T cells. Epidermal keratinocytes in the skin are able to express multiple chemokines that can attract certain leukocytes, such as T cells or dendritic cells (DCs), to migrate to the epidermis. Psoriasis is a type of skin inflammatory diseases that results in misregulated immune system including immune cell infiltration. Keratinocyte secreted chemokine and chemokine receptor on leukocytes have been known to involve in the pathogenesis of psoriasis. However, it is not very clear how chemokines are regulated in keratinocytes and the binding of chemokine to receptor on leukocytes controls the pathogenesis of psoriasis. To better understand the immune regulation of chemokine and chemokine receptor in the molecular mechanism and pathogenesis of psoriasis, the investigators plan to establish human psoriasis skin xenograft mouse model that involves graft of human skin onto immune deficient mice. The human skin, including lesional and non-lesional skins, has been proven to be acceptable to the SCID mice and the phenotype can maintain for a number of months. The advantage of the xenograft model is to that it can preserve the full complexity of human diseases and thus resembles the pathogenesis of human diseases. This model has also been shown with constant efficacy of anti-psoriasis drug in comparison with clinical practice. Thus, this mouse model has great value to help the investigators understand how chemokine and immune cells are regulated in psoriasis. Of particular note is that this model can be used to test therapeutic drug before introduce them into clinical trial.
- Conditions
- Psoriasis
- Being tested
- Shave Biopsy of Psoriasis Lesion
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shave Biopsy of Psoriasis LesionProcedure or surgery
Also called shave biopsy, biopsy, injection, lidocaine HCl with epinephrine
The investigator will take about 0.5x0.5 inch square section of skin from the psoriasis lesion. To numb the skin, the subject will receive a small injection of 0.5% lidocaine HCl 5mg/mL with 1:200,000 mcg/mL epinephrine solution as per standard shave biopsy protocol. The shaving instrument has a blade that will shave off a superficial piece of skin that is less than <3mm in thickness. After 14 days, the subject will return to make sure that the skin biopsy site has healed properly. The piece of skin that is removed will be grafted onto the back of an immunocompromised SCID mouse. An approved IACUC protocol covering this procedure will be in place prior to engraftment.
| Study group | Role | What they receive |
|---|---|---|
| Biopsy of Skin with Psoriasis | Shave biopsy of psoriasis lesion Receives: Procedure: Shave Biopsy of Psoriasis Lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of psoriatic skin from patient to transfer to immunocompromised mice
The purpose of this human clinical trial is to harvest psoriatic skin for engraftment onto immunocompromised mice. The primary outcome measure is to identify a 0.75 x 0.75 square inch piece of skin with psoriasis on study subjects to be biopsied. specific outcome measure that will be obtained in the patients other than ensuring that their graft sites heal appropriately. Their skin, once placed on immunocompromised mice, will be used to test new therapeutic drugs which might have a beneficial outcome in psoriasis, as measured in this mouse model.
Measured: Five years
Secondary outcomes (1)
Observe Appropriate Healing in Subject Biopsy sites
The secondary outcome measure is to observe that study subjects' graft sites heal appropriately.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start17 Apr 2017
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
Why it stopped: PI failed to submit study for continuing review by IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Samuel Hwang, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302390
- Sponsor's protocol ID
- 1015909
- Other IDs
- 5R01AR063091
- Status last verified
- Oct 2018
- First submitted
- 8 Jul 2017
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Chemokine and Chemokine Receptor in Psoriasis
- ClinicalTrials.gov ID
- NCT03302390
- Acronym / sponsor ID
- 1015909
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI failed to submit study for continuing review by IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 5 Oct 2017 (actual)
- 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.
This study aims to elucidate the role of Chemokine and chemokine receptor in the pathogenesis of Psoriasis by using human psoriasis skin xenograft SCID mouse model. The hypothesis is that chemokine and chemokine receptor play important roles in psoriasis and establishment of human skin xenograft mouse model provide excellent platform to test the hypothesis.
Detailed description
Chemokines belongs to a large group of small chemotactic proteins (8-11 kilodaltons in size). Upon engagement of chemokine, chemokine receptor can activate downstream intracellular signaling pathways and results in diverse cellular processing such as cytoskeleton reorganization and cell locomotion. Chemokines are chemoattractant factors and can stimulate directional migration of all classes of leukocytes such as T cells. Epidermal keratinocytes in the skin are able to express multiple chemokines that can attract certain leukocytes, such as T cells or dendritic cells (DCs), to migrate to the epidermis. Psoriasis is a type of skin inflammatory diseases that results in misregulated immune system including immune cell infiltration. Keratinocyte secreted chemokine and chemokine receptor on leukocytes have been known to involve in the pathogenesis of psoriasis. However, it is not very clear how chemokines are regulated in keratinocytes and the binding of chemokine to receptor on leukocytes controls the pathogenesis of psoriasis. To better understand the immune regulation of chemokine and chemokine receptor in the molecular mechanism and pathogenesis of psoriasis, the investigators plan to establish human psoriasis skin xenograft mouse model that involves graft of human skin onto immune deficient mice. The human skin, including lesional and non-lesional skins, has been proven to be acceptable to the SCID mice and the phenotype can maintain for a number of months. The advantage of the xenograft model is to that it can preserve the full complexity of human diseases and thus resembles the pathogenesis of human diseases. This model has also been shown with constant efficacy of anti-psoriasis drug in comparison with clinical practice. Thus, this mouse model has great value to help the investigators understand how chemokine and immune cells are regulated in psoriasis. Of particular note is that this model can be used to test therapeutic drug before introduce them into clinical trial.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy of Skin with Psoriasis | – | Procedure: Shave Biopsy of Psoriasis LesionShave biopsy of psoriasis lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years of age or greater will be recruited for this study. The study population will include patients at UC Davis Dermatology with diagnostic evidence for psoriasis who do not have coexisting inflammatory diseases.
Key inclusion criteria (5 listed)
- Subjects 18 years of age or greater
- Subjects need to fulfill the diagnostic evidence of psoriasis with or without psoriatic arthritis
- Subject may take the following medicines: NSAID, hydroxychloroquine, sulfasalazine, prednisone (<10 mg/day), Methotrexate (10 mg/week)
- Subject needs to stop topical skin preparations other than emollients in one small plaque of psoriasis for 3-4 wks from where the shave biopsy will be taken
- Willing and able to provide informed consent in English
Key exclusion criteria (6 listed)
- Subjects less than 18 years old
- no clinical evidence of psoriatic skin
- Subjects with contraindications for biopsy, and patients receiving anticoagulants
- Subjects with active hepatitis B or Hepatitis C infection
- Subjects with concomitant inflammatory diseases such as inflammatory bowel disease, gout
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 |
|---|---|---|
| Shave Biopsy of Psoriasis LesionAlso: shave biopsy, biopsy, injection, lidocaine HCl with epinephrineThe investigator will take about 0.5x0.5 inch square section of skin from the psoriasis lesion. To numb the skin, the subject will receive a small injection of 0.5% lidocaine HCl 5mg/mL with 1:200,000 mcg/mL epinephrine solution as per standard shave biopsy protocol. The shaving instrument has a blade that will shave off a superficial piece of skin that is less than <3mm in thickness. After 14 days, the subject will return to make sure that the skin biopsy site has healed properly. The piece of skin that is removed will be grafted onto the back of an immunocompromised SCID mouse. An approved IACUC protocol covering this procedure will be in place prior to engraftment. | Procedure or surgery | Biopsy of Skin with Psoriasis |
Primary outcome
Acquisition of psoriatic skin from patient to transfer to immunocompromised mice
Time frame: Five years
The purpose of this human clinical trial is to harvest psoriatic skin for engraftment onto immunocompromised mice. The primary outcome measure is to identify a 0.75 x 0.75 square inch piece of skin with psoriasis on study subjects to be biopsied. specific outcome measure that will be obtained in the patients other than ensuring that their graft sites heal appropriately. Their skin, once placed on immunocompromised mice, will be used to test new therapeutic drugs which might have a beneficial outcome in psoriasis, as measured in this mouse model.
1 secondary outcome
Observe Appropriate Healing in Subject Biopsy sites
Time frame: Five years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Samuel Hwang, M.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by University of California, Davis 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 17 Oct 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Acquisition of psoriatic skin from patient to transfer to immunocompromised mice (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2018.