Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-13 @ 1:55 PM
Study NCT ID:
NCT02751567
Status:
WITHDRAWN
Last Update Posted:
2016-05-23
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18776 - Human Photoallergy Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-20', 'studyFirstSubmitDate': '2016-04-22', 'studyFirstSubmitQcDate': '2016-04-22', 'lastUpdatePostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of skin reactions is evaluated by 5 point scale', 'timeFrame': 'Up to 72 hours'}]}, 'oversightModule': {'oversightHasDmc': 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 Health Insurance Portability and Accountability Act (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 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 and/or Bayer or is a household member of an employee"}, 'identificationModule': {'nctId': 'NCT02751567', 'briefTitle': '18776 - Human Photoallergy Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Human Photoallergy Test', 'orgStudyIdInfo': {'id': '18776'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'All subjects are patched with the same product', 'interventionNames': ['Other: BAY987516', 'Other: Untreated skin']}], 'interventions': [{'name': 'BAY987516', 'type': 'OTHER', 'description': '50 μl/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.', 'armGroupLabels': ['Arm 1']}, {'name': 'Untreated skin', 'type': 'OTHER', 'description': 'One site is patched without treatment as control', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}