Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-02 @ 4:10 AM
Study NCT ID:
NCT02309294
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2014-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'annahita.ghassemi@churchdwight.com', 'phone': '6098061200', 'title': 'Annahita Ghassemi', 'organization': 'Church & Dwight Co., Inc.'}, 'certainAgreement': {'otherDetails': 'Master service agreement and confidentiality agreement in place', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Healthy Subject', 'description': 'Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects That Showed no Significant Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subject', 'description': 'Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days', 'description': 'Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Subject', 'description': 'Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Subject', 'description': 'Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-72', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-05', 'studyFirstSubmitDate': '2014-12-03', 'resultsFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2014-12-04', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-05', 'studyFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects That Showed no Significant Irritation', 'timeFrame': '14 days', 'description': 'Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).'}]}, 'conditionsModule': {'keywords': ['Patch Test'], 'conditions': ['Cumulative Irritation']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are a male or female, 18 years of age or older, in general good health;\n* Have normal skin;\n* Are free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events;\n* Are of any skin type or race providing the skin pigmentation will allow discernment of erythema;\n* Complete a medical screening procedure; and\n* Read, understand, and sign an informed consent.\n\nExclusion Criteria:\n\n* Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation;\n* Are receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results;\n* Have psoriasis and/or active atopic dermatitis/eczema; and/or\n* Have a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated.'}, 'identificationModule': {'nctId': 'NCT02309294', 'briefTitle': '14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Church & Dwight Company, Inc.'}, 'orgStudyIdInfo': {'id': 'ST-7553'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Subject', 'description': 'Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).', 'interventionNames': ['Device: Novel lubricant Miami w/ fragrance', 'Device: Novel lubricant Miami no fragrance', 'Device: KY Liquid lubricant', 'Device: Astroglide Gel lubricant', 'Device: Wet Platinum lubricant']}], 'interventions': [{'name': 'Novel lubricant Miami w/ fragrance', 'type': 'DEVICE', 'description': '0.2 ml aliquot on occlusive patch', 'armGroupLabels': ['Healthy Subject']}, {'name': 'Novel lubricant Miami no fragrance', 'type': 'DEVICE', 'description': '0.2 ml aliquot on occlusive patch', 'armGroupLabels': ['Healthy Subject']}, {'name': 'KY Liquid lubricant', 'type': 'DEVICE', 'description': '0.2 ml aliquot on occlusive patch', 'armGroupLabels': ['Healthy Subject']}, {'name': 'Astroglide Gel lubricant', 'type': 'DEVICE', 'description': '0.2 ml aliquot on occlusive patch', 'armGroupLabels': ['Healthy Subject']}, {'name': 'Wet Platinum lubricant', 'type': 'DEVICE', 'description': '0.2 ml aliquot on occlusive patch', 'armGroupLabels': ['Healthy Subject']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07410', 'city': 'Fair Lawn', 'state': 'New Jersey', 'country': 'United States', 'facility': 'TKL Research, Inc.', 'geoPoint': {'lat': 40.94038, 'lon': -74.13181}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Church & Dwight Company, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}