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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04344574
Other study ID # interleukins in psoriasis
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date July 1, 2021

Study information

Verified date April 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 .


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date July 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with all types of psoriasis.

- healthy volunteers without a family history of psoriasis or other autoimmune disease.

Exclusion Criteria:

- other autoimmune , other chronic inflammatory or systemic diseases.

- cases received glucocorticoids, immunosuppressive drugs at least 1 month before sample collection .

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline
Primary 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). Baseline
Secondary 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. Baseline
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