Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT02885805
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2016-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sun Protection Factor (SPF) Efficacy 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': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2016-08-03', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sun Protection Factor (SPF) efficacy on the skin of human subjects before a total of 2 hours of water Immersion', 'timeFrame': 'up to 24 hours post-exposure', 'description': 'The subsites on each of the protected test sites \\[test sunscreen and/or Control\\] shall be exposed to UV light. The value of each subsite exposure shall be as appropriate to the test Method: the subject\'s Minimal Erythema Dose (MED) or MPPD Minimal Persistent Pigment Darkening Dose (MPPD) multiplied by the specific time intervals required. The unprotected skin site is divided into five subsites and shall also be exposed to UV light. The time intervals selected are a geometric series represented by (1.25)n, (n = the subjects MED or MPPD, at the middle \\[3"\'\\] subsite) wherein each exposure time interval is 25 percent greater than the previous time or intensity. The SPF of each TM for each subject is then calculated from the exposure time interval required to produce the MED or MPPD of the protected skin, and from the exposure time interval required to produce the MED or MPPD of the unprotected skin.'}, {'measure': 'Sun Protection Factor (SPF) efficacy on the skin of human subjects after a total of 2 hours of water Immersion', 'timeFrame': 'up to 24 hours post-exposure', 'description': 'The subsites on each of the protected test sites \\[test sunscreen and/or Control\\] shall be exposed to UV light. The value of each subsite exposure shall be as appropriate to the test Method: the subject\'s Minimal Erythema Dose (MED) or MPPD Minimal Persistent Pigment Darkening Dose (MPPD) multiplied by the specific time intervals required. The unprotected skin site is divided into five subsites and shall also be exposed to UV light. The time intervals selected are a geometric series represented by (1.25)n, (n = the subjects MED or MPPD, at the middle \\[3"\'\\] subsite) wherein each exposure time interval is 25 percent greater than the previous time or intensity. The SPF of each TM for each subject is then calculated from the exposure time interval required to produce the MED or MPPD of the protected skin, and from the exposure time interval required to produce the MED or MPPD of the unprotected skin.'}]}, '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* Fitzpatrick Skin Type I, II and/or 111 for UVB testing; Fitzpatrick Skin Type II, 111 and/or IV for UVA testing.\n* Sex: Male or female.\n* Age: 18-70 years.\n* Good health as determined from the HRL SHF.\n* Signed and dated lnformed Consent Form.\n* Signed and dated HIPAA Form.\n* An unambiguous MED or MPPD'}, 'identificationModule': {'nctId': 'NCT02885805', 'briefTitle': 'Sun Protection Factor (SPF) Efficacy Assay', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Sun Protection Factor (SPF) Efficacy Assay', 'orgStudyIdInfo': {'id': '18322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPF evaluation + Control', 'description': 'Fair-skinned subjects in good health with Skin Types I, II or III.', 'interventionNames': ['Drug: BAY987516', 'Drug: SPF 15 Control']}], 'interventions': [{'name': 'BAY987516', 'type': 'DRUG', 'description': '2.00 mg/cm2 ± 0.04 mg/cm2', 'armGroupLabels': ['SPF evaluation + Control']}, {'name': 'SPF 15 Control', 'type': 'DRUG', 'description': '2.00 mg/cm2 ± 0.04 mg/cm2', 'armGroupLabels': ['SPF evaluation + Control']}]}, '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'}}}}