Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-01 @ 3:01 AM
Study NCT ID:
NCT02737618
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2016-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon
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': 'Confidentiality agreement in place with PI', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Healthy Subject', 'description': 'Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch\n\nTrojan "Chameleon" Personal Lubricant: silicone base with sensate', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subject', 'description': 'Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch\n\nTrojan "Chameleon" Personal Lubricant: silicone base with sensate'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subject', 'description': 'Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch\n\nTrojan "Chameleon" Personal Lubricant: silicone base with sensate'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Subject', 'description': 'Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch\n\nTrojan "Chameleon" Personal Lubricant: silicone base with sensate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Subject', 'description': 'Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch\n\nTrojan "Chameleon" Personal Lubricant: silicone base with sensate'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-69', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2016-03-22', 'resultsFirstSubmitDate': '2017-08-02', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-02', 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale', 'timeFrame': '14 days'}, {'measure': 'Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale', 'timeFrame': '14 days'}]}, 'oversightModule': {'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dermal Irritation']}, 'descriptionModule': {'briefSummary': 'to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female, 18-70 years of age, in general good health\n* normal skin\n* 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* of any skin type or race providing the skin pigmentation will allow discernment of erythema\n* agree to complete a medical history and concomitant medication form\n* read, understand and sign 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 systemic 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\n* have a known sensitivity to cosmetics, skin care test articles, or topical drugs as related to the test article being evaluated\n* are females who are pregnant or breastfeeding or become pregnant'}, 'identificationModule': {'nctId': 'NCT02737618', 'briefTitle': '14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon', 'organization': {'class': 'INDUSTRY', 'fullName': 'Church & Dwight Company, Inc.'}, 'orgStudyIdInfo': {'id': 'ST-7611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy subject', 'description': 'Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch', 'interventionNames': ['Device: Trojan "Chameleon" Personal Lubricant']}], 'interventions': [{'name': 'Trojan "Chameleon" Personal Lubricant', 'type': 'DEVICE', 'description': 'silicone base with sensate', '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}}], 'overallOfficials': [{'name': 'John Dosik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TKL Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Church & Dwight Company, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}