Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-03-02 @ 10:05 AM
Study NCT ID:
NCT00843466
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2008-06-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006229', 'term': 'Hand Dermatoses'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jamie.Regan@unilever.com', 'phone': '203-381-4448', 'title': 'Jamie Regan', 'organization': 'Unilever'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Test Product', 'description': 'The test group was provided with a test product for all hand cleansing needs during the duration of the study.', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group (Current Product)', 'description': 'The control group continued to use their current cleanser for hand washing.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator Global Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Moisturizing Hand Cleanser Test Product', 'description': 'The test group was provided with a test product for all hand cleansing needs during the duration of the study.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'The control group continued to use their current cleanser for hand washing.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.2'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '1.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Wk 4', 'description': 'Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Product', 'description': 'The test group was provided with a test product for all hand cleansing needs during the duration of the study.'}, {'id': 'FG001', 'title': 'Control Group (Current Product)', 'description': 'The control group continued to use their current cleanser for hand washing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment was from May 22,2007 to May 12, 2008 at Wake Forest University in Winston Salem.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Product', 'description': 'The test group was provided with a test product for all hand cleansing needs during the duration of the study.'}, {'id': 'BG001', 'title': 'Control Group (Current Product)', 'description': 'The control group continued to use their current cleanser for hand washing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '78'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '65'}, {'value': '41', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2008-06-02', 'resultsFirstSubmitDate': '2010-11-12', 'studyFirstSubmitQcDate': '2009-02-12', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-26', 'studyFirstPostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Global Assessment', 'timeFrame': 'Wk 4', 'description': 'Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hand dermatitis'], 'conditions': ['Hand Dermatosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if the use of a hand cleanser that adds moisture to the skin will help improve skin rashes caused by frequent hand washing (hand dermatitis).', 'detailedDescription': 'The objective of this protocol is to evaluate compatibility and potential benefits of daily use of a marketed mild, moisturizing hand cleanser for subjects/patients who experience mild to moderate hand dermatitis induced by frequent cleansing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 65 years of age\n* In general good health\n* Hands free of cuts and abrasions\n* Agree to adhere to the requirements listed in the informed consent\n* Willing and able to use a mild, moisturizing, non-antibacterial cleanser for all hand washing purposes for the duration of the test period\n* Willing to refrain from participating in any other clinical research trial for the duration of the study\n\nExclusion Criteria:\n\n* Documented allergies to study product components, soaps, latex, or fragrances\n* History of the following conditions which may affect the response of the skin or the interpretation of the results: insulin dependent diabetes, or peripheral vascular diseases\n* Participating in a concurrent clinical study involving treatment of your hands\n* Currently using a prescription medication for hand dermatitis'}, 'identificationModule': {'nctId': 'NCT00843466', 'briefTitle': 'Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis', 'orgStudyIdInfo': {'id': 'IRB00002004'}, 'secondaryIdInfos': [{'id': '31963'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mild moisturizing Hand Cleanser', 'description': 'The test group will be provided with a mild moisturizing hand cleanser for all hand cleansing needs during the duration of the study.', 'interventionNames': ['Other: Mild, moisturizing hand cleanser']}, {'type': 'NO_INTERVENTION', 'label': 'Current Hand Cleanser', 'description': 'The control group will continue to use their current cleanser for all hand washing.'}], 'interventions': [{'name': 'Mild, moisturizing hand cleanser', 'type': 'OTHER', 'description': 'Hand cleanser ingredient list:\n\nAmmonium Lauryl Sulfate, Ammonium Laureth Sulfate, Cocamide MEA, PEG-5 Cocamide Cocamidopropyl Betaine Sodium Lauroyl Sarcosinate Glycerin Petrolatum Soybean Oil Sodium Hydroxypropyl Starch Phosphate Lauric Acid Lauryl Alcohol PEG-14M Guar hydroxypropyl trimonium chloride DMDM Hydantoin; Iodopropynyl Butylcarbamate Etidronic Acid Tetrasodium EDTA Titanium Dioxide Fragrance Sodium Hydroxide Water', 'armGroupLabels': ['Mild moisturizing Hand Cleanser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences Dermatology', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Alan Fleischer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}