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Serum Level of IL-33 in Egyptian Psoriatic Patients

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07557095
Acronym
CYC-IL33-PSO
Enrollment
118
Registered
2026-04-29
Start date
2026-06-01
Completion date
2027-03-01
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Egyptian Psoriatic Patients

Brief summary

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_TESTserum 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_TESTPASI 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

Sponsors

scientific_committee
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
differences of the serum IL-33 levels in psoriatic patientsmaesure the serum level of IL-33 before and after 3 months from taking Methotrexate and Cyclosporinecompare between Methotrexate and Cyclosporine in psoriatic patients in the IL-33 serum levels after use the drug for 3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026