Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 2:46 PM
Study NCT ID:
NCT06370650
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Platelet Rich Plasma on Outcome of Narrow Band UVB in Treatment of Vitiligo; Clinical and Histopathological Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-13', 'studyFirstSubmitDate': '2024-04-13', 'studyFirstSubmitQcDate': '2024-04-13', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of vitiligo', 'timeFrame': 'within 6 months', 'description': 'increase repigmentation score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Management of Stable Vitiligo']}, 'descriptionModule': {'briefSummary': 'For each patient, one side of body will be treated with NB-UVB alone while the other side will be treated with NB-UVB therapy in addition to intradermal injection of PRP every 2 weeks. Patients will be photographed at the first visit, in the middle and at the end of therapy. Each patient will sign a written consent form to be included in the study and to be photographed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with stable non segmental vitiligo. (Absence of koebnerization, absence of new lesion and absence of widening of the existing lesions).\n\nPatients have more than 15 years.\n\n\\-\n\nExclusion Criteria:\n\nPatients have active vitiligo (appearance of new lesion, history of koebnerization).\n\nPregnant and lactating women. History of keloid formation. Anemia (hemoglobin level \\<10gm/dl), thrombocytopenia (platelet count \\<100,000 /µL), coagulopathies or patients on anticoagulant therapy and patients with iron deficiency.\n\nPatients taking drugs that prolong bleeding time such as Aspirin and vitamin E Patients taking treatment of vitiligo in last 2 months'}, 'identificationModule': {'nctId': 'NCT06370650', 'briefTitle': 'Effect of Platelet Rich Plasma on Outcome of Narrow Band UVB in Treatment of Vitiligo; Clinical and Histopathological Study', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Effect of Platelet Rich Plasma on Outcome of Narrow Band UVB in Treatment of Vitiligo; Clinical and Histopathological Study', 'orgStudyIdInfo': {'id': 'soh-med-24-1-9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Narrow band UVB', 'interventionNames': ['Procedure: platelet rich plasma, narrow band UVB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet rich plasma plus narrow band UVB', 'interventionNames': ['Procedure: platelet rich plasma, narrow band UVB']}], 'interventions': [{'name': 'platelet rich plasma, narrow band UVB', 'type': 'PROCEDURE', 'description': 'Role of PRP in treating stable vitiligo', 'armGroupLabels': ['Narrow band UVB', 'Platelet rich plasma plus narrow band UVB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82515', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Researcher shall pubish in national journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assissant lecturer', 'investigatorFullName': 'Sara Hassan Ahmed', 'investigatorAffiliation': 'Sohag University'}}}}