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Serum Granulysin Level as a Marker to Detect the Severity of Psoriasis

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ClinicalTrials.gov Identifier: NCT03469219
Recruitment Status : Unknown
Verified March 2018 by Yasmin Sayed, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 19, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Yasmin Sayed, Assiut University

Study Description
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Brief Summary:

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
Psoriasis Vulgaris

Detailed Description:

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 Design
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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Groups and Cohorts
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Group/Cohort
Study group
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.
Control group
Healthy volunteers. measuring serum granulysin level for all healthy volunteers and tissue granulysin level for a number of them using Enzyme Linked Immunosorbent Assay.


Outcome Measures
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Primary Outcome Measures :
  1. serum granulysin level [ Time Frame: 1 hour ]
    blood samples will be collected and measuring serum granulysin level using Enzyme Linked Immunosorbent Assay


Secondary Outcome Measures :
  1. 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

  2. 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
  1. Blood samples will be taken from peripheral veins for all subjects.
  2. 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.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Dermatology clinic at Assiut University.
Criteria

Inclusion Criteria:

  • Patients with clinically typical psoriatic lesions of different ages and sex.
  • Patients with psoriasis vulgaris .
  • Different degrees of severity according to Psoriasis Area and Index (PASI) Score

Exclusion Criteria:

  • Pregnant and lactating women.
  • Patients received systemic medical treatment in the last one month.
  • Patients with associated disease reported to increase the release of granulysin whether systemic e.g(infection, cancer, organ transplantation, autoimmune disease) or skin e.g( lichen planus , steven Johnson syndrome, toxic epidermal necrolysis, viral vesicles) and patients with severe immune deficiency treated by cell therapy.
Contacts and Locations
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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): NCT03469219


Contacts
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Contact: Radwa Bakr, assis prof 01119988115 Radwabakr2011@hotmail.com
Contact: Tarek El Melegy, Lecturer 01095472946 t_elmelegy@yahoo.com

Locations
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Egypt
Assiut University
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Hisham Diab, assis prof Assiut University
More Information
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Additional Information:

Publications:

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Responsible Party: Yasmin Sayed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03469219    
Other Study ID Numbers: SGLPSS
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasmin Sayed, Assiut University:
granulysin
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases