Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 1:20 PM
Study NCT ID:
NCT06546059
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gasdermin D Expression in Generalized Vitiligo Patients After Narrow-band Ultraviolet B Therapy
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-08-05', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.', 'timeFrame': 'three months', 'description': '1- Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.techniques in patients with generalized vitiligo and compare it with healthy controls.'}], 'secondaryOutcomes': [{'measure': '2- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.', 'timeFrame': 'three months', 'description': '2- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.'}, {'measure': '3- Determine whether there is a correlation between tissue immunehistochemstry Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.', 'timeFrame': 'three months', 'description': '3- Determine whether there is a correlation between tissue immunehistochemstry D levels and disease duration and involved body surface area (VISA) in vitiligo patients.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitiligo, Generalized']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to:\n\n1. Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.\n2. Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.\n3. Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.', 'detailedDescription': 'The aim of this study is to:\n\n1. Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.\n2. Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.\n3. Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with stable vitiligo of 6 months duration,\n* Both sex and ages(10-75)\n\nExclusion Criteria:\n\n* pregnancy,\n* lactation,\n* patients under or previous phototherapy,\n* patients on other immunosuppressives,\n* patients receiving topical or systemic therapy like antioxidants and vitamins were kept off treatment for 2 weeks prior to recruitment into the study.'}, 'identificationModule': {'nctId': 'NCT06546059', 'briefTitle': 'Gasdermin D Expression in Generalized Vitiligo Patients After Narrow-band Ultraviolet B Therapy', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Gasdermin D Expression in Generalized Vitiligo Patients After Narrow-band Ultraviolet B Therapy', 'orgStudyIdInfo': {'id': 'SVU-MED-,4-24,7,871'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'one group', 'interventionNames': ['Device: narrow band ultraviolet-B']}], 'interventions': [{'name': 'narrow band ultraviolet-B', 'type': 'DEVICE', 'description': 'vitiligo patients will recevie twice sessions per week', 'armGroupLabels': ['one group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Soheir Abdel-Hamid, MD', 'role': 'CONTACT', 'email': 'soher.abdel-hamid@med.svu.edu.eg', 'phone': '01066877343'}, {'name': 'Basma Tito Abd Elhameed, MD', 'role': 'CONTACT', 'email': 'Basma.tito@med.svu.edu.eg', 'phone': '01020304210'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Soheir Abdel-Hamid, principle investigator', 'investigatorFullName': 'Soheir Abdelhamid', 'investigatorAffiliation': 'South Valley University'}}}}