Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 1:43 PM
Study NCT ID:
NCT02930759
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2016-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sun Protection Factor Assay (SPF Assay 200/2016)
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': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2016-10-10', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimal Erythema Dose (MED)', 'timeFrame': 'Up to 15 minutes'}, {'measure': 'Minimal Persistent Pigment Darkening Dose (MPPD)', 'timeFrame': 'Up to 15 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sunscreening Agents']}, 'descriptionModule': {'briefSummary': 'To evaluate the Sun Protection Factor efficacy on human skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.\n* Male and female.\n* Aged between 18-70 years old.\n* Good health as determined from the HRL SHF (Subject History Form).\n* Signed and dated Informed Consent Form.\n* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.\n* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).\n\nExclusion Criteria:\n\n* Subjects on test at any other research laboratory or clinic.\n* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.\n* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.\n* Pre-existing other medical conditions (e.g. adult asthma, diabetes).\n* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.\n* Treatment with antibiotics within two weeks prior to initiation of the test.\n* Chronic medication which could affect the results of the study.\n* Known pregnant or nursing women.'}, 'identificationModule': {'nctId': 'NCT02930759', 'briefTitle': 'Sun Protection Factor Assay (SPF Assay 200/2016)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose', 'orgStudyIdInfo': {'id': '19200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY987516', 'description': 'Each test site area is divided into test sub site areas that are approximately at least 0.5 cm\\*2. The application of test material is 2 mg/cm\\*2. Thus, each 50 cm\\*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\\*2 test application.', 'interventionNames': ['Drug: BAY987516']}], 'interventions': [{'name': 'BAY987516', 'type': 'DRUG', 'description': 'Each 50 cm\\*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\\*2 test application. (Formulation Code: Z46-096)', 'armGroupLabels': ['BAY987516']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07083', 'city': 'Union', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.6976, 'lon': -74.2632}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}