Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-28 @ 12:59 AM
Study NCT ID:
NCT05734235
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2023-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UVB-Induced MVP Release in Human Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D014810', 'term': 'Vitamin E'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-13', 'size': 219693, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-20T17:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-02-08', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in microvesicle particles (MVP) levels from baseline', 'timeFrame': 'Day 8', 'description': 'Levels of microvesicle particles will be determined from skin biopsies'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultraviolet B Radiation', 'Microvesicle Particles']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess if ultraviolet B radiation (UVB) found in sunlight causes the release of microvesicle particles in human skin, and if antioxidant vitamins can block their production.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects\n* Ages 21 to 45\n* Skin type: Fitzpatrick Type I or II\n\nExclusion Criteria:\n\n* Have underlying diseases that could affect wound healing\n* On medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS \\[except for low-dose aspirin\\] or steroids)\n* History of abnormal scarring (e.g., keloids)\n* Should not be on Vitamin C or E supplements for past month\n* Unable to understand/complete informed consent\n* Large volar arm tattoos that would inhibit the ability to conduct/evaluate the skin testing\n* Renal compromise/kidney stones or allergy to Vitamin C/Vitamin E or lidocaine anaesthetic\n* Use of tanning bends or recent UVB exposure to the areas in the past 3 months\n* Recent (within 1 week) use to sunscreen to volar forearms'}, 'identificationModule': {'nctId': 'NCT05734235', 'briefTitle': 'UVB-Induced MVP Release in Human Skin', 'organization': {'class': 'OTHER', 'fullName': 'Wright State University'}, 'officialTitle': 'Ultraviolet B Radiation-Induced Microvesicle Particle Release in Human Skin', 'orgStudyIdInfo': {'id': '06201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C & Vitamin E', 'description': 'After subjects undergo UVB treatment then they will be instructed to take two Vitamin C and one Vitamin E tablets daily for 8 days.', 'interventionNames': ['Dietary Supplement: Vitamin C', 'Dietary Supplement: Vitamin E']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two Vitamin C tablets daily for 8 days.', 'armGroupLabels': ['Vitamin C & Vitamin E']}, {'name': 'Vitamin E', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One Vitamin E tablet daily for 8 days.', 'armGroupLabels': ['Vitamin C & Vitamin E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45324', 'city': 'Fairborn', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wright State Physicians', 'geoPoint': {'lat': 39.82089, 'lon': -84.01938}}], 'overallOfficials': [{'name': 'Jeffrey B Travers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wright State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wright State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}