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

• Conditions: Psoriasis Vulgaris

• Registration Number: NCT03469219
• Lead Sponsor: Assiut University

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.

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 Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-19
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23
• Study Start: 2018-07
• Primary Completion: 2018-12
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serum granulysin level	1 hour	blood samples will be collected and measuring serum granulysin level using Enzyme Linked Immunosorbent Assay

Secondary Outcome Measures

Name	Time	Method
lesional tissue granulysin level	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	24 hours	punch tissue biopsy will be taken from perilesional skin, and homogenized then granulysin level measured using Enzyme Linked Immunosorbent Assay

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt