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

NCT ID: NCT03469219

Last Updated: 2018-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yasmin Sayed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hisham Diab, assis prof

Role: STUDY_DIRECTOR

Assiut University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut University

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Radwa Bakr, assis prof

Role: CONTACT

01119988115

Tarek El Melegy, Lecturer

Role: CONTACT

01095472946

References

Explore related publications, articles, or registry entries linked to this study.

Elgarhy LH, Shareef MM, Moustafa SM. Granulysin expression increases with increasing clinical severity of psoriasis. Clin Exp Dermatol. 2015 Jun;40(4):361-6. doi: 10.1111/ced.12560. Epub 2015 Feb 2.

Reference Type BACKGROUND
PMID: 25639185 (View on PubMed)

Vicic M, Peternel S, Simonic E, Sotosek-Tokmadzic V, Massari D, Brajac I, Kastelan M, Prpic-Massari L. Cytotoxic T lymphocytes as a potential brake of keratinocyte proliferation in psoriasis. Med Hypotheses. 2016 Feb;87:66-8. doi: 10.1016/j.mehy.2015.12.004. Epub 2015 Dec 12.

Reference Type BACKGROUND
PMID: 26826643 (View on PubMed)

Massari D, Prpic-Massari L, Kehler T, Kastelan M, Curkovic B, Persic V, Ruzic A, Laskarin G. Analysis of granulysin-mediated cytotoxicity in peripheral blood of patients with psoriatic arthritis. Rheumatol Int. 2012 Sep;32(9):2777-84. doi: 10.1007/s00296-011-2013-9. Epub 2011 Aug 10.

Reference Type BACKGROUND
PMID: 21830153 (View on PubMed)

Ogawa E, Sato Y, Minagawa A, Okuyama R. Pathogenesis of psoriasis and development of treatment. J Dermatol. 2018 Mar;45(3):264-272. doi: 10.1111/1346-8138.14139. Epub 2017 Dec 10.

Reference Type BACKGROUND
PMID: 29226422 (View on PubMed)

Endsley JJ, Torres AG, Gonzales CM, Kosykh VG, Motin VL, Peterson JW, Estes DM, Klimpel GR. Comparative antimicrobial activity of granulysin against bacterial biothreat agents. Open Microbiol J. 2009 Jun 5;3:92-6. doi: 10.2174/1874285800903010092.

Reference Type BACKGROUND
PMID: 19587798 (View on PubMed)

Murphy M, Kerr P, Grant-Kels JM. The histopathologic spectrum of psoriasis. Clin Dermatol. 2007 Nov-Dec;25(6):524-8. doi: 10.1016/j.clindermatol.2007.08.005.

Reference Type BACKGROUND
PMID: 18021888 (View on PubMed)

Nair RP, Ding J, Duffin KC, Helms C, Voorhees JJ, Krueger GG, Bowcock AM, Abecasis GR, Elder JT. Psoriasis bench to bedside: genetics meets immunology. Arch Dermatol. 2009 Apr;145(4):462-4. doi: 10.1001/archdermatol.2009.73. No abstract available.

Reference Type BACKGROUND
PMID: 19380669 (View on PubMed)

Ogawa K, Takamori Y, Suzuki K, Nagasawa M, Takano S, Kasahara Y, Nakamura Y, Kondo S, Sugamura K, Nakamura M, Nagata K. Granulysin in human serum as a marker of cell-mediated immunity. Eur J Immunol. 2003 Jul;33(7):1925-33. doi: 10.1002/eji.200323977.

Reference Type BACKGROUND
PMID: 12884856 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://journals.lww.com/jewds/Fulltext/2011/01000/Does_the_antimicrobial_peptide,_granulysin,_play_a.10.aspx?trendmd-shared=0

The Journal of The Egyptian Women's Dermatologic Society :Does the antimicrobial peptide, granulysin, play a role in decreasing the incidence of secondary bacterial infection in psoriasis?

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SGLPSS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Excimer Light in Psoriasis
NCT05283876 COMPLETED NA