Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-13 @ 3:23 AM
Study NCT ID:
NCT02872233
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2016-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay
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': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2015-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2016-08-05', 'studyFirstSubmitQcDate': '2016-08-17', 'lastUpdatePostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of 2 hours water resistant SPF', 'timeFrame': '16-24 h post exposure', 'description': 'ISO/COLIPA Sun Protection FactorTest Method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sunscreen Agents']}, 'descriptionModule': {'briefSummary': 'Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female of an age of 18 to 70 years inclusive;\n* Fitzpatrick Skin Type I, II and/or III for SPF testing;\n* Good health as determined from the CRO Subject History Form (SHF);\n* Signed and dated Informed Consent Form;\n* Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form;\n* An unambiguous minimal erythema dose (MED).'}, 'identificationModule': {'nctId': 'NCT02872233', 'briefTitle': 'Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay', 'orgStudyIdInfo': {'id': '18319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPF evaluation', 'description': 'Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing.', 'interventionNames': ['Drug: BAY 987519', 'Drug: SPF 15 Control']}], 'interventions': [{'name': 'BAY 987519', 'type': 'DRUG', 'description': 'Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.', 'armGroupLabels': ['SPF evaluation']}, {'name': 'SPF 15 Control', 'type': 'DRUG', 'description': 'Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.', 'armGroupLabels': ['SPF evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07083', 'city': 'Union', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.6976, 'lon': -74.2632}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}