Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-21 @ 10:56 PM
Study NCT ID:
NCT02754102
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Phototoxicity Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2016-04-22', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of skin reactions will be evaluated using the 5 point grading scale', 'timeFrame': 'Up to 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sunscreening Agents']}, 'descriptionModule': {'briefSummary': 'To determine the phototoxic potential of a topically applied article in human subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* be male or female between the ages of 18 and 60 inclusive;\n* be lightly pigmented (Fitzpatrick Skin Type I, II, III);\n* have read and signed the written Informed Consent Form and have completed a HIPAA (Health Insurance Portability and Accountability Act) Authorization Form in conformance with 45CFR (Code of Federal Regulations ) Parts 160 and 164;\n* be in general good health as determined by the subject's medical history and in the discretion of the investigator.\n\nExclusion Criteria:\n\n* have a visible sunburn;\n* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis;\n* must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.\n* have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products."}, 'identificationModule': {'nctId': 'NCT02754102', 'briefTitle': 'Human Phototoxicity Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Human Phototoxicity Test', 'orgStudyIdInfo': {'id': '18775'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sunscreen Spray-Liquid', 'description': 'All subjects are patched with the same product', 'interventionNames': ['Other: Sunscreen Spray- Liquid (BAY987516)']}], 'interventions': [{'name': 'Sunscreen Spray- Liquid (BAY987516)', 'type': 'OTHER', 'description': '50 μl/cm\\*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back.', 'armGroupLabels': ['Sunscreen Spray-Liquid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}