Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-03-10 @ 11:45 PM
Study NCT ID:
NCT07001904
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2025-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interleukin-6 in Plaque Psoriasis and Its Possible Role in Disease Severity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004797', 'term': 'Enzyme-Linked Immunosorbent Assay'}], 'ancestors': [{'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007163', 'term': 'Immunosorbent Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-25', 'studyFirstSubmitDate': '2025-05-24', 'studyFirstSubmitQcDate': '2025-05-25', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease severity', 'timeFrame': '3 months post-procedure', 'description': 'Disease severity was assessed using the Psoriasis Area and Severity Index (PASI), categorizing patients into mild (PASI \\<5), moderate (PASI 5-10), and severe (PASI \\>10) groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interleukin-6', 'Plaque Psoriasis', 'Disease Severity']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate serum IL-6 levels in plaque psoriasis patients and investigate their correlation with disease severity.', 'detailedDescription': 'Psoriasis is a chronic, immune-mediated inflammatory dermatological condition that impacts around 0.2% to 4.8% of the worldwide population.\n\nInterleukin (IL)-6 is a pleiotropic cytokine that regulates immunity, hematopoiesis, and inflammation. It is produced by keratinocytes, endothelial cells, fibroblasts, and immune cells like macrophages and dendritic cells. Increased IL-6 expression has been observed in psoriatic lesions, suggesting its involvement in disease pathogenesis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This cross-sectional work had been performed on 30 individuals with plaque psoriasis and 20 sex- and age-matched healthy controls.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18 years.\n* Both sexes.\n* Patients clinically diagnosed with plaque psoriasis.\n\nExclusion Criteria:\n\n* Patients who had received any treatment for psoriasis in the last three months.\n* Patients with other types of psoriasis.\n* Those currently receiving systemic treatment.\n* Individuals with other inflammatory diseases.\n* Pregnant or lactating women.\n* Those using contraceptive pills.\n* Patients with metabolic conditions like diabetes mellitus or thyroid disorders.'}, 'identificationModule': {'nctId': 'NCT07001904', 'briefTitle': 'Interleukin-6 in Plaque Psoriasis and Its Possible Role in Disease Severity', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Interleukin-6 in Plaque Psoriasis and Its Possible Role in Disease Severity', 'orgStudyIdInfo': {'id': '36264MS308/9/23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients group', 'description': 'Patients with plaque psoriasis.', 'interventionNames': ['Other: Enzyme-linked immunosorbent assay (ELISA)']}, {'label': 'Control group', 'description': 'Sex- and age-matched healthy control individuals.', 'interventionNames': ['Other: Enzyme-linked immunosorbent assay (ELISA)']}], 'interventions': [{'name': 'Enzyme-linked immunosorbent assay (ELISA)', 'type': 'OTHER', 'description': 'The enzyme-linked immunosorbent assay (ELISA) was utilized in order to determine the levels of IL-6 in the serum', 'armGroupLabels': ['Control group', 'Patients group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Adel Jamal Khaled Jadallah', 'investigatorAffiliation': 'Tanta University'}}}}