Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT07184203
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Continuous and Pulse Itraconazole in Tinea Capitis in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014006', 'term': 'Tinea Capitis'}], 'ancestors': [{'id': 'D014005', 'term': 'Tinea'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012536', 'term': 'Scalp Dermatoses'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2025-09-14', 'studyFirstSubmitQcDate': '2025-09-14', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of tinea capitis', 'timeFrame': '3 months', 'description': 'cure of tinea capitis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tinea Capitis']}, 'descriptionModule': {'briefSummary': 'A study to compare the efficacy of daily therapy versus pulse therapy of oral itraconazole in the treatment of tinea capitis in children based on clinical, mycological and dermoscopic evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Tinea capitis patients with ages ranging from 5 to 18 year\n\nExclusion Criteria:\n\n* Patients with contraindications to itraconazole\n* Patients with associated scalp disease.\n* Patients weighing less than 20 Kg.'}, 'identificationModule': {'nctId': 'NCT07184203', 'briefTitle': 'Comparison Between Continuous and Pulse Itraconazole in Tinea Capitis in Children', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Comparative Clinicomycologic and Dermoscopic Study Between Daily and Pulse Therapy of Oral Itraconazole in Tinea Capitis in Children', 'orgStudyIdInfo': {'id': '0108853'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A will receive itraconazole continuous daily regimen', 'interventionNames': ['Drug: Itraconazole (ITZ)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B will receive itraconazole pulse regimen', 'interventionNames': ['Drug: Itraconazole (ITZ)']}], 'interventions': [{'name': 'Itraconazole (ITZ)', 'type': 'DRUG', 'description': 'therapy for tinea capitis orally', 'armGroupLabels': ['Group A will receive itraconazole continuous daily regimen', 'Group B will receive itraconazole pulse regimen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Marina K Aioub', 'role': 'CONTACT', 'email': 'marinaaioub10@gmail.com', 'phone': '00201223805043'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'general practitioner', 'investigatorFullName': 'Marina Aioub', 'investigatorAffiliation': 'Alexandria University'}}}}