Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT02739802
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2016-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18751-Sun Protection Factor 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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2016-04-13', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03-30', '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 (SPF) efficacy on human skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: - Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. - Male or female - Aged between 18-70 years old. - Good health - Signed and dated Informed Consent Form - Signed and dated Health Insurance Portability and Accountability Authorization (HIPAA) Form - An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: - Subjects on test at any other research laboratory or clinic. - Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. - PRe-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. - Pre-existing other medical conditions (e.g. adult asthma. diabetes). - Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. - Treatment with antibiotics within two weeks prior to initiation of the test - Chronic medication which could affect the results of the study. - Known pregnant or nursing women.'}, 'identificationModule': {'nctId': 'NCT02739802', 'acronym': 'SPF Assay', 'briefTitle': '18751-Sun Protection Factor Assay.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose', 'orgStudyIdInfo': {'id': '18751'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY 987517', 'description': 'Each test site area is divided into test subsite 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: Coppertone(BAY987517)']}], 'interventions': [{'name': 'Coppertone(BAY987517)', '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 number - SR16-02.', 'armGroupLabels': ['BAY 987517']}]}, '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'}}}}