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Not yet recruiting NCT07557095

Serum Level of IL-33 in Egyptian Psoriatic Patients

Observational Egyptian Psoriatic Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: serum interleukin 33 measurement, PASI score.
Who it may be relevant to
Registry conditions: Egyptian Psoriatic Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Cyclosporine Mitigated the Augmented Serum Level of IL-33 in Egyptian Psoriatic Patients in Relation to Disease Severity

Overview

This study aimed to compare the serum concentration levels of IL-33 in psoriatic patients undergoing treatment with two commonly prescribed immunosuppressive drugs, methotrexate and cyclosporine. Blood samples will be collected, Serum IL-33 concentrations will be measured using enzyme-linked immunosorbent assay (ELISA) techniques. Clinical assessments, including Psoriasis Area and Severity Index (PASI) scores, will be also recorded to evaluate disease severity and treatment efficacy.

Detailed description

Psoriasis is a chronic immune-mediated disease with significant clinical and immunological heterogeneity. Although methotrexate and cyclosporine are widely used in moderate to severe psoriasis, their comparative effects on IL-33 - a key pro-inflammatory cytokine - have not been adequately evaluated. In this randomized controlled trial involving 118 Egyptian psoriatic patients, we directly compared the therapeutic efficacy of methotrexate versus cyclosporine and analyzed their impact on serum IL-33 levels in relation to Psoriasis Area and Severity Index (PASI).

Our findings demonstrated that while both drugs significantly reduced PASI scores and IL-33 serum levels, cyclosporine showed superior efficacy and achieved a greater reduction in both clinical severity and IL-33. A strong positive correlation was observed between IL-33 levels and PASI scores, supporting IL-33 as a reliable biomarker of disease activity and therapeutic response.

This is one of the few clinical studies in Egypt and the region evaluating IL-33 modulation in psoriasis therapy. Our results may guide clinicians in selecting optimal systemic treatment and highlight IL-33 as a potential therapeutic target.

Interventions

  • Diagnostic test serum interleukin 33 measurement
    Blood samples will be collected from participants under aseptic conditions. Serum will be separated and stored appropriately. Serum Interleukin-33 (IL-33) levels will be measured using enzyme-linked immunosorbent assay (ELISA) to evaluate its association with psoriasis.
  • Diagnostic test PASI score
    The Psoriasis Area and Severity Index (PASI) is the most widely utilized quantitative tool in clinical dermatology and pharmacological research for grading the severity of chronic plaque psoriasis. It provides a composite score based on the clinical manifestation of the disease across distinct anatomical regions

Primary outcome measures

  • differences of the serum IL-33 levels in psoriatic patients [Time frame: maesure the serum level of IL-33 before and after 3 months from taking Methotrexate and Cyclosporine]

Eligibility criteria

Inclusion criteria

  • Patient included who had age more than 18 years old from both sexes, and manifested with moderate to severe psoriasis (according to the body surface area BSA): moderate; BSA 5-10 and severe; BSA > 10)

Exclusion criteria

  • Patient excluded from the study, who was pregnant or lactating women, and patient who had associated comorbidity namely inflammatory, autoimmune diseases , systemic diseases (mainly hypertension, renal, and hepatic diseases). In addition presence of any dermatologic diseases other than psoriasis, and history of receiving other systemic drugs, phototherapy for psoriasis within the last 6 months, or hypersensitivity to methotrexate and/or cyclosporine. Lastly, patients with body dismorphic disorders were also excluded.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07557095 · pharmacology1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗