Serum Granulysin Level as a Marker to Detect the Severity of Psoriasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03469219|
Recruitment Status : Not yet recruiting
First Posted : March 19, 2018
Last Update Posted : March 23, 2018
Psoriasis is a chronic inflammatory and proliferative papulosquamous skin disease of unknown cause,overexpression of Anti Microbial Peptides is characteristic of psoriasis.
Granulysin is a cytolytic and proinflammatory peptide that belongs to a family of saposin-like, lipid binding antimicrobial peptides, and localized in the granular compartments of cytotoxic T lymphocytes and natural killer cells,Patients with psoriasis had high tissue granulysin expression, which increased with increased clinical severity of the disease.
The aim of the study is to measure serum granulysin level and correlate with severity of psoriasis and tissue level of granulysin.
|Condition or disease|
The pathogenesis of psoriasis involves dynamic interactions between multiple cell types and numerous cytokines in response to triggers in genetically predisposed individuals leading to activation of T cells and their migration into skin, in addition to dysregulation of immunological cell function, keratinocyte proliferation takes place.
Psoriatic lesions are densely infiltrated by T cells and dendritic cells , the majority of T cells in the dermis are T-helper cells, while T cytotoxic cells predominate in the epidermis. T helper1 secrets cytokines, such as interferon gamma, tumor necrosis factor-alpha and interleukin 12. Recently discovered population of T helper cells called T helper17 cells which secrets interleukin 17 and interleukin 22 which stimulates epidermal proliferation, while interleukin 17 is responsible for the release of proinflammatory cytokines, antimicrobial peptides and chemokines.
A significant upregulation of perforin-expressing lymphocytes, especially cytotoxic T cells and natural killer cells, has been observed in psoriatic patients at the systemic and local levels. Perforin is a prototype granular cytotoxic mediator that ensures the quick access of pro-apoptotic molecules, such as granzymes and granulysin, into the target cells to induce apoptosis .
Granulysin is well associated with diverse activities of natural killer cells and cytotoxic T cells in physiological and pathological settings and could be a useful serum marker for monitoring host cell mediated immune cytotoxic responses.
Granulysin contributes toward the defense mechanisms against mycobacterial and viral infections as it can kill microbial pathogens through disruption of their membrane integrity, this can explain why infections is extremely rare in psoriatic lesions as psoriasis had high tissue granulysin expression, which increased with increased clinical severity of the disease.
Granulysin was found in the sera of healthy individuals at minimal concentrations.
No previous studies performed to detect the level of serum granulysin in patients with psoriasis vulgaris.
|Study Type :||Observational|
|Estimated Enrollment :||45 participants|
|Official Title:||Serum Granulysin as a Possible Key Marker to Detect the Severity of Psoriasis|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||March 2019|
patients with psoriasis vulgaris. measuring serum granulysin level for all patients and tissue granulysin level in lesional and perilesional skin for a number of patients using Enzyme Linked Immunosorbent Assay.
Healthy volunteers. measuring serum granulysin level for all healthy volunteers and tissue granulysin level for a number of them using Enzyme Linked Immunosorbent Assay.
- serum granulysin level [ Time Frame: 1 hour ]blood samples will be collected and measuring serum granulysin level using Enzyme Linked Immunosorbent Assay
- lesional tissue granulysin level [ Time Frame: 24 hours ]punch tissue biopsy will be taken from lesions, and homogenized then granulysin level measured using Enzyme Linked Immunosorbent Assay
- perilesional tissue granulysin level [ Time Frame: 24 hours ]punch tissue biopsy will be taken from perilesional skin, and homogenized then granulysin level measured using Enzyme Linked Immunosorbent Assay
Biospecimen Retention: Samples With DNA
- Blood samples will be taken from peripheral veins for all subjects.
- Punch tissue biopsy will be taken from lesional and perilesional skin for a number of patients in the study group and normal tissue samples for a number of control group subjects.
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): NCT03469219
|Contact: Radwa Bakr, assis prof||01119988115||Radwabakr2011@hotmail.com|
|Contact: Tarek El Melegy, Lecturerfirstname.lastname@example.org|
|Study Director:||Hisham Diab, assis prof||Assiut University|