Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT02962869
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2016-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Photoallergy Test (824/2016)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-12-31', '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': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of skin reactions is evaluated by 5 point scale', 'timeFrame': 'Up to 72 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sunscreening Agents']}, 'descriptionModule': {'briefSummary': 'To evaluate the potential of a test material to produce a photoallergic response'}, '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 (Health Insurance Portability and Accountability Act) 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 dermatoses\n* have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products\n* subjects who are employees of the CRO (Contract Research Organization) and/or Bayer or is a household member of an employee"}, 'identificationModule': {'nctId': 'NCT02962869', 'briefTitle': 'Human Photoallergy Test (824/2016)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Human Photoallergy Test', 'orgStudyIdInfo': {'id': '18824'}}, '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 the test article is applied directly to two sites on the skin and covered with the appropriate patch. Twenty-four (24) hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm\\*2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. Forty-eight (48) hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. (Formulation number: Z43-078)', 'armGroupLabels': ['BAY987517']}, {'name': 'Untreated skin', 'type': 'OTHER', 'description': 'One site is patched without treatment as 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'}}}}