Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-04 @ 3:36 AM
Study NCT ID:
NCT02962856
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2016-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Phototoxicity Test (823/2016)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2016-11-10', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-05', '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, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': 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 Authorization Form in conformance with 45CFR 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': 'NCT02962856', 'briefTitle': 'Human Phototoxicity Test (823/2016)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Human Phototoxicity Test', 'orgStudyIdInfo': {'id': '18823'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY987517', 'description': 'All subjects are patched with the same product.', 'interventionNames': ['Drug: BAY987517', 'Other: Untreated Skin']}], 'interventions': [{'name': 'BAY987517', 'type': 'DRUG', '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. (Formulation: Z43-078)', 'armGroupLabels': ['BAY987517']}, {'name': 'Untreated Skin', 'type': 'OTHER', 'description': 'This site is patched without treatment as irradiated control', 'armGroupLabels': ['BAY987517']}]}, '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'}}}}