Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-29 @ 6:52 AM
Study NCT ID:
NCT03371758
Status:
UNKNOWN
Last Update Posted:
2018-01-23
First Post:
2017-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2017-12-05', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression of LC3-I, LC3-II & Beclin 1 in vitiligo patients', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autophagy']}, 'descriptionModule': {'briefSummary': 'The exact mechanism of impairment of autophagy in vitiligo has not yet been determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients with non-segmental vitiligo whether active or stable.\n\n * Age above 12 years.\n * Both sexes.\n\nExclusion Criteria:\n\n* • Patients should not use any topical or systemic treatment at least 6 weeks before inclusion into the study.\n\n * Patients having other autoimmune disease, heart disease, liver disease, kidney disease, neurological disorder, cancer, active infection or any chronic disease.\n * Pregnancy or breast feeding for female patients.'}, 'identificationModule': {'nctId': 'NCT03371758', 'briefTitle': 'Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo and Healthy Control; Comparative Study', 'orgStudyIdInfo': {'id': 'Dermatology'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vitiligo patients', 'interventionNames': ['Other: skin biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'healthy controls', 'interventionNames': ['Other: skin biopsy']}], 'interventions': [{'name': 'skin biopsy', 'type': 'OTHER', 'description': 'Punch skin biopsy will be taken from the lesional and non-lesional skin of vitiligo patients as well as healthy skin of controls.', 'armGroupLabels': ['healthy controls', 'vitiligo patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Maha Fathy Elmasry, MD', 'role': 'CONTACT', 'email': 'mahafathy1214@gmail.com'}], 'facility': 'Maha Fathy Elmasry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Maha Fathy Elmasry', 'investigatorAffiliation': 'Cairo University'}}}}