Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT01887860
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2013-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patch Test Skin Irritation/Sensitization of Cetaphil Daily Facial Moisturizer SPF 50
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': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2013-06-24', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area of erythema and edema measured', 'timeFrame': '3 consecutive weeks', 'description': '9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks'}]}, 'conditionsModule': {'keywords': ['Cetaphil Daily Facial Moisturizer SPF 50'], 'conditions': ['Skin Irritation']}, 'descriptionModule': {'briefSummary': 'Determine if Cetaphil Daily Facial Moisturizer SPF 50 proves to be a contact sensitizer or irritant in certain individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Not currently under a doctor's care\n* Free of dermatological or systemic disorder which would interfere with the results\n* Free of any acute or chronic disease\n* Will complete a preliminary medical history form and are in general good health\n* Can read, understand, and sign informed consent\n\nExclusion Criteria:\n\n* Under 18 years old\n* Currently under doctor's care\n* Currently taking any medication\n* History of acute or chronic disease\n* Diagnosed with chronic skin allergies\n* Pregnant or lactating"}, 'identificationModule': {'nctId': 'NCT01887860', 'briefTitle': 'Patch Test Skin Irritation/Sensitization of Cetaphil Daily Facial Moisturizer SPF 50', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)', 'orgStudyIdInfo': {'id': 'GLI.04.SRE.US10232c'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cetaphil Daily Facial Moisturizer SPF50', 'description': 'All subjects receive Cetaphil Daily Facial Moisturizer SPF 50', 'interventionNames': ['Other: Cetaphil Daily Facial Moisturizer SPF 50']}], 'interventions': [{'name': 'Cetaphil Daily Facial Moisturizer SPF 50', 'type': 'OTHER', 'description': 'Other: Cetaphil Daily Advance Ultra Hydrating Lotion 0.2ml or 0.2g of Cetaphil on occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks', 'armGroupLabels': ['Cetaphil Daily Facial Moisturizer SPF50']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10956', 'city': 'New City', 'state': 'New York', 'country': 'United States', 'facility': 'AMA Laboratories', 'geoPoint': {'lat': 41.1476, 'lon': -73.98931}}], 'overallOfficials': [{'name': 'Mayya Tastene, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMA Laboratories'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}