Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT03832751
Status:
UNKNOWN
Last Update Posted:
2019-02-06
First Post:
2019-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Beta-defensin 1 in Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2019-02-05', 'studyFirstSubmitQcDate': '2019-02-05', 'lastUpdatePostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tissue levels of human beta-defensin 1 before and after NB-UVB phototherapy', 'timeFrame': '6 months to 1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitiligo']}, 'descriptionModule': {'briefSummary': 'There is a need to know the role of human beta defensin-1 in vitiligo pathogenesis and the probability of finding newer and effective therapy for vitiligo in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-segmental vitiligo.\n* Both genders.\n* Age more than 18 years old.\n* New cases or cases not receiving any treatment for at least 3 months prior to the study.\n\nExclusion Criteria:\n\n* Universal or segmental vitiligo.\n* Any contraindication to phototherapy treatment.\n* History of autoimmune diseases or other systemic diseases.\n* Any other skin disease.'}, 'identificationModule': {'nctId': 'NCT03832751', 'briefTitle': 'Human Beta-defensin 1 in Vitiligo', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Estimation of Tissue Level of Human Beta-defensin 1 (HBD-1) in Vitiligo Before and After Narrowband UVB Phototherapy: a Case-control Study', 'orgStudyIdInfo': {'id': 'Dermatology 12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vitiligo patients', 'description': 'Tissue levels of human beta-defensin 1 in vitiligo patients before and after NB-UVB phototherapy', 'interventionNames': ['Other: skin biopsy before and after NB-UVB phototherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy controls', 'description': 'Tissue levels of human beta-defensin 1 in healthy controls', 'interventionNames': ['Other: skin biopsy before and after NB-UVB phototherapy']}], 'interventions': [{'name': 'skin biopsy before and after NB-UVB phototherapy', 'type': 'OTHER', 'description': 'skin biopsy before and after NB-UVB phototherapy to measure tissue human beta-defensin 1', 'armGroupLabels': ['Healthy controls', 'vitiligo patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Maha Fathy Elmasry', 'investigatorAffiliation': 'Cairo University'}}}}