Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-05 @ 2:35 AM
Study NCT ID:
NCT01892657
Status:
COMPLETED
Last Update Posted:
2022-08-01
First Post:
2013-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elizabeth.nieman@galderma.com', 'phone': '817-961-5130', 'title': 'Elizabeth M. Nieman, Medical Information Specialist', 'organization': 'Galderma Laboratories, L.P.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Facial Moisturizer With SPF 50+', 'description': 'All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+', 'otherNumAtRisk': 110, 'otherNumAffected': 0, 'seriousNumAtRisk': 110, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area of Erythema and Elevated Responses of Skin to Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '110', 'groupId': 'OG005'}, {'value': '110', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}, {'value': '110', 'groupId': 'OG008'}, {'value': '110', 'groupId': 'OG009'}, {'value': '110', 'groupId': 'OG010'}, {'value': '110', 'groupId': 'OG011'}, {'value': '110', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Patch 1', 'description': 'Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+'}, {'id': 'OG001', 'title': 'Patch 2', 'description': 'Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+'}, {'id': 'OG002', 'title': 'Patch 3', 'description': 'Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+'}, {'id': 'OG003', 'title': 'Patch 4', 'description': 'Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+'}, {'id': 'OG004', 'title': 'Patch 5', 'description': 'Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+'}, {'id': 'OG005', 'title': 'Patch 6', 'description': 'Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+'}, {'id': 'OG006', 'title': 'Patch 7', 'description': 'Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+'}, {'id': 'OG007', 'title': 'Patch 8', 'description': 'Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+'}, {'id': 'OG008', 'title': 'Patch 9', 'description': 'Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+'}, {'id': 'OG009', 'title': 'Challenge Patch (Original Site) - 48 Hours', 'description': 'The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded at 48 hours.'}, {'id': 'OG010', 'title': 'Challenge Patch (Original Site) - 96 Hours', 'description': 'The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded again at 96 hours.'}, {'id': 'OG011', 'title': 'Challenge Patch (Alternate Site) - 48 Hours', 'description': 'A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded at 48 hours.'}, {'id': 'OG012', 'title': 'Challenge Patch (Alternate Site) - 96 Hours', 'description': 'A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded again at 96 hours.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '78', 'groupId': 'OG009'}, {'value': '85', 'groupId': 'OG010'}, {'value': '86', 'groupId': 'OG011'}, {'value': '95', 'groupId': 'OG012'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}, {'value': '72', 'groupId': 'OG006'}, {'value': '72', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '31', 'groupId': 'OG009'}, {'value': '24', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 consecutive weeks', 'description': 'Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Facial Moisturizer With SPF 50+', 'description': 'All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'Subjects were screened at a single US center.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Facial Moisturizer With SPF 50+', 'description': 'All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.0', 'spread': '13.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian/Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects who were enrolled in the study and participated in all scheduled visits during the study were analyzed.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2013-07-01', 'resultsFirstSubmitDate': '2013-07-23', 'studyFirstSubmitQcDate': '2013-07-03', 'lastUpdatePostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-07-23', 'studyFirstPostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area of Erythema and Elevated Responses of Skin to Product', 'timeFrame': '3 consecutive weeks', 'description': 'Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cetaphil Daily Facial Moisturizer with SPF 50+', 'Hypoallergenicity', 'Skin Irritation'], 'conditions': ['Skin Irritation']}, 'descriptionModule': {'briefSummary': 'This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.', 'detailedDescription': 'The design for this study is standard for human repeat insult patch tests. To test the moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals of the moisturizer to the upper back. Patches were remained on the skin for approximately 48 to 72 hours. Twelve to 24 days after the previous applications, subjects were patched with the moisturizer at the original site and an alternative site for 48 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women 18 to 70 years of age in general good health\n* Can read, understand, and sign informed consent\n\nExclusion Criteria:\n\n* History of acute or chronic disease\n* Diagnosed with chronic skin allergies\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT01892657', 'briefTitle': 'Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)', 'orgStudyIdInfo': {'id': 'GLI.04.SRE.US10093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Facial Moisturizer with SPF 50+', 'description': 'All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+', 'interventionNames': ['Drug: Facial Moisturizer with SPF 50+']}], 'interventions': [{'name': 'Facial Moisturizer with SPF 50+', 'type': 'DRUG', 'otherNames': ['Cetaphil Daily Facial Moisturizer with SPF 50+'], 'description': 'All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+', 'armGroupLabels': ['Facial Moisturizer with SPF 50+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89015', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Thomas J. Stephens and Associates, Inc.', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}], 'overallOfficials': [{'name': 'Ronald Gottschalk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}