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

NCT03469219 | Unknown

• 1 other identifier: SGLPSS
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris

Keywords

granulysin

Outcome Measures

Primary Outcomes (1)

• serum granulysin level

  blood samples will be collected and measuring serum granulysin level using Enzyme Linked Immunosorbent Assay

  1 hour

Secondary Outcomes (2)

• lesional tissue granulysin level

  24 hours

• perilesional tissue granulysin level

  24 hours

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dermatology clinic at Assiut University.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (8)

• 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.

  PMID: 25639185 BACKGROUND

• 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.

  PMID: 26826643 BACKGROUND

• 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.

  PMID: 21830153 BACKGROUND

• 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.

  PMID: 29226422 BACKGROUND

• 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.

  PMID: 19587798 BACKGROUND

• 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.

  PMID: 18021888 BACKGROUND

• 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.

  PMID: 19380669 BACKGROUND

• 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.

  PMID: 12884856 BACKGROUND

Related Links

• 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?

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.

Study Officials

• Hisham Diab, assis prof

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Radwa Bakr, assis prof

CONTACT

01119988115; Radwabakr2011@hotmail.com

Tarek El Melegy, Lecturer

CONTACT

01095472946; t_elmelegy@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 19, 2018
• Study Start: July 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

EG (1)