Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:39 PM
Study NCT ID:
NCT06889506
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-21
First Post:
2025-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interleukin-4 in Pityriasis Lichenoides Chronica
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017514', 'term': 'Pityriasis Lichenoides'}], 'ancestors': [{'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010267', 'term': 'Parapsoriasis'}, {'id': 'D010915', 'term': 'Pityriasis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-16', 'studyFirstSubmitDate': '2025-03-16', 'studyFirstSubmitQcDate': '2025-03-16', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of tissue and serum levels of interleukin 4 (IL -4) in pityriasis lichenoides chronica (PLC) patients and normal controls.', 'timeFrame': '6 months', 'description': 'measurement of tisssue and serum levels of interleukin 4 (IL -4) in pityriasis lichenoides chronica (PLC) patients and comparing them with normal controls to control and verify the hypothesisof involvement of IL-4 in the pathogenesis of PLC'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pityriasis Lichenoides']}, 'descriptionModule': {'briefSummary': 'assessment of the level of interleukin 4 (IL-4) in the lesional skin and serum of PLC patients and compare its level with healthy controls.', 'detailedDescription': "measuring the level of Interleukin 4 in lesional skin and it's serum level using ELIZA in patients with Pityriasis lichenoides chronica and comparing the levels with healthy controls levels"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pityriasis lichenoides Chronica (PLC): either with the classical presentation papular or hypo-pigmented macules and patches that proved histopathologically to be PLC.\n* Both genders\n* Age group ≥ 8 years\n\nExclusion Criteria:\n\n* Patients with other skin diseases\n* Patient received treatment for PLC within period less than three months\n* Pregnant patients\n* Lactating patients'}, 'identificationModule': {'nctId': 'NCT06889506', 'briefTitle': 'Interleukin-4 in Pityriasis Lichenoides Chronica', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of Interleukin-4 Tissue and Serum Levels in Pityriasis Lichenoides Chronica Patients : a Case- Control Study', 'orgStudyIdInfo': {'id': 'Dermatology 20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PLC patients', 'description': 'one skin biopsy (lesional) and serum sample will be taken from every patient', 'interventionNames': ['Procedure: skin biopsy and serum sample']}, {'type': 'EXPERIMENTAL', 'label': 'healthy controls', 'description': 'a skin biopsy and serum sample will be taken from each control sample', 'interventionNames': ['Procedure: skin biopsy and serum sample']}], 'interventions': [{'name': 'skin biopsy and serum sample', 'type': 'PROCEDURE', 'description': 'skin biopsy from lesional skin and serum sample will be taken from each patient . also a skin biopsy and serum sample will be taken from each healthy control', 'armGroupLabels': ['PLC patients', 'healthy controls']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mona Mostafa Korany Mahmoud', 'investigatorAffiliation': 'Cairo University'}}}}