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Role of Chemokine and Chemokine Receptor in Psoriasis

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ClinicalTrials.gov Identifier: NCT03302390
Recruitment Status : Withdrawn (PI failed to submit study for continuing review by IRB)
First Posted : October 5, 2017
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of California, Davis

Brief 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 excellent platform to test the hypothesis.

Condition or disease Intervention/treatment
Psoriasis Procedure: Shave Biopsy of Psoriasis Lesion

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Role of Chemokine and Chemokine Receptor in Psoriasis
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : April 13, 2018
Actual Study Completion Date : April 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Psoriasis

Group/Cohort Intervention/treatment
Biopsy of Skin with Psoriasis
Shave biopsy of psoriasis lesion
Procedure: Shave Biopsy of Psoriasis Lesion
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.
Other Names:
  • shave biopsy
  • biopsy
  • injection, lidocaine HCl with epinephrine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Observe Appropriate Healing in Subject Biopsy sites [ Time Frame: Five years ]
    The secondary outcome measure is to observe that study subjects' graft sites heal appropriately.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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): NCT03302390


Locations
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United States, California
UC Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Samuel Hwang, M.D. University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03302390     History of Changes
Other Study ID Numbers: 1015909
5R01AR063091 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Lidocaine
Epinephrine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents