Psoriasis VulgarisNCT03469219
Serum Granulysin Level as a Marker to Detect the Severity of Psoriasis
An observational study of Psoriasis Vulgaris, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2018to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Dermatology clinic at Assiut University.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Granulysin as a Possible Key Marker to Detect the Severity of Psoriasis
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.
Read the 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.
- Conditions
- Psoriasis Vulgaris
- Keywords
- granulysin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum granulysin level
blood samples will be collected and measuring serum granulysin level using Enzyme Linked Immunosorbent Assay
Measured: 1 hour
Secondary outcomes (2)
lesional tissue granulysin level
punch tissue biopsy will be taken from lesions, and homogenized then granulysin level measured using Enzyme Linked Immunosorbent Assay
Measured: 24 hours
perilesional tissue granulysin level
punch tissue biopsy will be taken from perilesional skin, and homogenized then granulysin level measured using Enzyme Linked Immunosorbent Assay
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study startJul 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Sayed, Assiut University
- Investigators
- Hisham Diab, assis prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469219
- Sponsor's protocol ID
- SGLPSS
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25639185Vicic 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.
PubMed 26826643Massari 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.
PubMed 21830153Ogawa 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.
PubMed 29226422Endsley 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.
PubMed 19587798Murphy 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.
PubMed 18021888Nair 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.
PubMed 19380669Ogawa 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.
PubMed 12884856
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Granulysin as a Possible Key Marker to Detect the Severity of Psoriasis
- ClinicalTrials.gov ID
- NCT03469219
- Acronym / sponsor ID
- SGLPSS
- Conditions
- Psoriasis Vulgaris
- Keywords
- granulysin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Dermatology clinic at Assiut University.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum granulysin level
Time frame: 1 hour
blood samples will be collected and measuring serum granulysin level using Enzyme Linked Immunosorbent Assay
2 secondary outcomes
lesional tissue granulysin level
Time frame: 24 hours
perilesional tissue granulysin level
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Background: PubMed 25639185Elgarhy 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.
- Background: PubMed 26826643Vicic 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.
- Background: PubMed 21830153Massari 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.
- Background: PubMed 29226422Ogawa 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.
- Background: PubMed 19587798Endsley 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.
- Background: PubMed 18021888Murphy 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.
- Background: PubMed 19380669Nair 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.
- Background: PubMed 12884856Ogawa 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.
- 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?Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hisham Diab, assis prof study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radwa Bakr, assis prof (01119988115, Radwabakr2011@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum granulysin level (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469219, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.