PsoriasisNCT04344574
Serum Level of IL31,33 and 36 in Egyptian Paients With Psoriasis
An observational study of Psoriasis, run by Assiut University.
Trial summary
Evaluating Serum Level Of IL 31 , IL33 and IL36 and Their Correlation with Disease Activity In Patients With Psoriasis In Assuit University Hospital . To correlate their levels with disease activity using PASI score . To allow better understanding of the pathophysiological mechanism of the disease . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Jul 2021
- 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
- Child, Adult, Older adult
Study population: study will be performed on 45 psoriasis patients and 45 healthy matched volunteers without a family history of psoriasis and other autoimmune as well as inflammatory diseases and underwent no systemic treatment including glucocorticoids, immunosuppressive drugs, or phototherapy at least 1 month before the PASI score ,evaluation and sample collection period . All patients will be recruited from the Psoriasis Clinic in Dermatology Department of Assuit University Hospital
Who may be able to join
- Patients with all types of psoriasis.
- healthy volunteers without a family history of psoriasis or other autoimmune disease.
Who cannot join
- other autoimmune , other chronic inflammatory or systemic diseases.
- cases received glucocorticoids, immunosuppressive drugs at least 1 month before sample collection .
About this study
Official title: Serum Level of IL31,33 and 36 in Egyptian Paients With Psoriasis in Assiut University Hospital : Case Control Study
Evaluating Serum Level Of IL 31 , IL33 and IL36 and Their Correlation with Disease Activity In Patients With Psoriasis In Assuit University Hospital .
- To correlate their levels with disease activity using PASI score .
- To allow better understanding of the pathophysiological mechanism of the disease .
Read the detailed description
Serum samples will be collected from 45 psoriasis patients and 45 matched healthy individuals. After full history taking and dermatological examination, the disease severity will be assessed using the psoriasis area and severity index (PASI) score. All patients enrolled in our study had no other autoimmune or systemic diseases and underwent no systemic treatment including glucocorticoids, immunosuppressive drugs, or phototherapy at least 1 month before the PASI score evaluation and sample collection period. Wriiten informed consent will be obtained from all the patients and healthy controls.
Assessment of serum interleukin-31 ,33 and 36 concentrations in psoriatic patients Patients and controls Blood samples will collected from psoriatic patients and controls, and will centrifuged for 15 min at 1000 rpm. Next, the serum samples will be subdivided into small aliquots to be stored at -80°C until analysis for cytokine levels. ELISA kits will be used to determine serum IL-31 , 33 and 36
- Conditions
- Psoriasis
- Keywords
- interleukine 31,33 and 36
- Medical subject headings
- Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
describe the serum levels of IL31, IL33 and IL36 in egyptian patients with psoriasis.
- Blood samples will collected from psoriatic patients and controls.
- using ELISA kits to measure serum concentration of IL31 [pg/ml] , IL33 [pg/ml] and IL36 [pg/ml] .
- p value less than 0,05 reflect significant increase in serum levels of measured interleukins.
Measured: Baseline
4. Knowing the extent of disease activity by Psoriasis Area and Severity Index (PASI) score.
assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Measured: Baseline
Secondary outcomes (1)
serum level of interleukins reflect severity of disease and represent anovel target for antipsoriatic drug theraby.
increase of the serum level of interleukins during disease activity means significant increase which has a value in drug therapy of psoriasis . and vice versa.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Elzahraa Adel Ismail, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344574
- Sponsor's protocol ID
- interleukins in psoriasis
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Level of IL31,33 and 36 in Egyptian Paients With Psoriasis in Assiut University Hospital : Case Control Study
- ClinicalTrials.gov ID
- NCT04344574
- Acronym / sponsor ID
- interleukins in psoriasis
- Conditions
- Psoriasis
- Keywords
- interleukine 31,33 and 36
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 14 Apr 2020 (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.
Evaluating Serum Level Of IL 31 , IL33 and IL36 and Their Correlation with Disease Activity In Patients With Psoriasis In Assuit University Hospital .
- To correlate their levels with disease activity using PASI score .
- To allow better understanding of the pathophysiological mechanism of the disease .
Detailed description
Serum samples will be collected from 45 psoriasis patients and 45 matched healthy individuals. After full history taking and dermatological examination, the disease severity will be assessed using the psoriasis area and severity index (PASI) score. All patients enrolled in our study had no other autoimmune or systemic diseases and underwent no systemic treatment including glucocorticoids, immunosuppressive drugs, or phototherapy at least 1 month before the PASI score evaluation and sample collection period. Wriiten informed consent will be obtained from all the patients and healthy controls.
Assessment of serum interleukin-31 ,33 and 36 concentrations in psoriatic patients Patients and controls Blood samples will collected from psoriatic patients and controls, and will centrifuged for 15 min at 1000 rpm. Next, the serum samples will be subdivided into small aliquots to be stored at -80°C until analysis for cytokine levels. ELISA kits will be used to determine serum IL-31 , 33 and 36
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- study will be performed on 45 psoriasis patients and 45 healthy matched volunteers without a family history of psoriasis and other autoimmune as well as inflammatory diseases and underwent no systemic treatment including glucocorticoids, immunosuppressive drugs, or phototherapy at least 1 month before the PASI score ,evaluation and sample collection period . All patients will be recruited from the Psoriasis Clinic in Dermatology Department of Assuit University Hospital
Key inclusion criteria (2 listed)
- Patients with all types of psoriasis.
- healthy volunteers without a family history of psoriasis or other autoimmune disease.
Key exclusion criteria (2 listed)
- other autoimmune , other chronic inflammatory or systemic diseases.
- cases received glucocorticoids, immunosuppressive drugs at least 1 month before sample collection .
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
describe the serum levels of IL31, IL33 and IL36 in egyptian patients with psoriasis.
Time frame: Baseline
1. Blood samples will collected from psoriatic patients and controls. 2. using ELISA kits to measure serum concentration of IL31 [pg/ml] , IL33 [pg/ml] and IL36 [pg/ml] . 3. p value less than 0,05 reflect significant increase in serum levels of measured interleukins.
4. Knowing the extent of disease activity by Psoriasis Area and Severity Index (PASI) score.
Time frame: Baseline
assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
1 secondary outcome
serum level of interleukins reflect severity of disease and represent anovel target for antipsoriatic drug theraby.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Assiut University.
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 2 inclusion and 2 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 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
describe the serum levels of IL31, IL33 and IL36 in egyptian patients with psoriasis. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2020.