Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-02-21 @ 11:26 AM
Study NCT ID:
NCT02842268
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2016-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-07-20', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent).', 'timeFrame': 'At baseline and post exercise (30 minutes)', 'description': 'Done with a Skin Scanner( before and after each exercise session) using the 11-point scale'}], 'secondaryOutcomes': [{'measure': 'Eye Stinging on grading scale', 'timeFrame': 'Up to 30 mins', 'description': 'On scale:0 = None,1 = Slight,2 = Mild,3 = Moderate, 4 = Severe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sunscreening Agent']}, 'descriptionModule': {'briefSummary': 'To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects may be male or female, of an age of 18-55 years inclusive.\n* Subjects must be capable of understanding and providing written informed consent.\n* Subjects must sign a written confidentiality agreement including a photography release form.\n* Subjects must be in good general health as judged by a specified licensed physician, who will indicate their suitability to participate in this study.\n* Female subjects must be willing to take a rapid screen pregnancy test prior to each exercise session.\n* Subjects must be willing to follow study instructions as set forth in the protocol.\n* Subjects must not have facial piercing(s).\n* Subjects must be Fitzpatrick Skin Type I, II, or III.\n\nExclusion Criteria:\n\n* Subjects must not have received or used an Investigational New Drug within the last 30 days.\n* Subjects must not have been active participants in another clinical or subjective TP performance study within the last 30 days unless authorized by this Sponsor.\n* Subjects must not have a known physical or medical condition that would preclude vigorous exercise\n* Subjects must not have a five-minute resting pulse rate greater than 80 bpm.\n* Subjects must not take any chronic medication other than vitamins, hormone replacement therapy, low-dose aspirin, or oral contraceptives.\n* Subjects must not have applied prescription or over-the-counter medicines to their face at least 96 hours prior to exercise session\n* Subjects must not have a known allergy or sensitivity to sunscreen products or Cetaphil cleanser.\n* Female subjects must not be pregnant (self-reported) or test positive using an on-site pregnancy test.\n* Female subjects must not be nursing a child.\n* Subjects must not have smoked cigarettes, pipes, or cigars in the last 60 days.\n* Subjects who in the judgment of the Investigator have any condition that would make study participation inappropriate.\n* Subjects must not be a member or relative of the clinical trial staff or the Sponsor directly involved in the study.'}, 'identificationModule': {'nctId': 'NCT02842268', 'briefTitle': 'Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating', 'orgStudyIdInfo': {'id': '18818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY987517', 'description': 'Subject will self-apply the test sunscreen formula to his/her face with the goal of applying 0.65 to 0.85 grams.Subject should sweat profusely.', 'interventionNames': ['Drug: BAY987517']}], 'interventions': [{'name': 'BAY987517', 'type': 'DRUG', 'description': 'Test product dried for at least 15 minutes.Subjects to ride for 30 minutes on a stationary bicycle.(Formulation Number :Y73-161)', 'armGroupLabels': ['BAY987517']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33714', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}