Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2026-03-08 @ 10:22 AM
Study NCT ID:
NCT02299206
Status:
TERMINATED
Last Update Posted:
2018-03-13
First Post:
2014-11-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CeraVe Cream Compared to Desitin Paste for Treating Diaper Dermatitis in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003963', 'term': 'Diaper Rash'}], 'ancestors': [{'id': 'D017453', 'term': 'Dermatitis, Irritant'}, {'id': 'D003877', 'term': 'Dermatitis, Contact'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'NUdermatologyCTU@northwestern.edu', 'phone': '312-503-5944', 'title': 'Dermatology CTU', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina', 'description': 'Healthy 3-18 months old infants with mild to moderate diaper dermatitis.\n\nCeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.\n\nArms are combined for reporting of adverse events. Due to the low number of subjects, data will not be analyzed and the arm assignment for the subjects was not determined.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina', 'description': 'Healthy 3-18 months old infants with mild to moderate diaper dermatitis.\n\nCeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.'}], 'timeFrame': '14 days', 'description': 'For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to analysis due to low enrollment.'}, {'type': 'SECONDARY', 'title': 'Change in Physician Assessment Diaper Dermatitis Scores to Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina', 'description': 'Healthy 3-18 months old infants with mild to moderate diaper dermatitis.\n\nCeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.'}], 'timeFrame': '7 days', 'description': 'For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to analysis due to low enrollment.'}, {'type': 'SECONDARY', 'title': 'Parents/Caregivers Daily Scores Through Duration of the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina', 'description': 'Healthy 3-18 months old infants with mild to moderate diaper dermatitis.\n\nCeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.'}], 'timeFrame': '14 days', 'description': "Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level", 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to analysis due to low enrollment.'}, {'type': 'SECONDARY', 'title': 'Assessment of Tolerability by the Infant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina', 'description': 'Healthy 3-18 months old infants with mild to moderate diaper dermatitis.\n\nCeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.'}], 'timeFrame': '14 days', 'description': "Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a VAS severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level", 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to analysis due to low enrollment.'}, {'type': 'SECONDARY', 'title': 'Parent/Caregiver Rating of Satisfaction With Use of the Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina', 'description': 'Healthy 3-18 months old infants with mild to moderate diaper dermatitis.\n\nCeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.'}], 'timeFrame': '14 days', 'description': 'Parents/caregivers will be given a questionnaire rating the use of the study products.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to analysis due to low enrollment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina', 'description': 'Healthy 3-18 months old infants with mild to moderate diaper dermatitis.\n\nCeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Arms are combined for overall number of participants. Due to the low number of subjects, data will not be analyzed and the arm assignment for the subjects was not determined.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina', 'description': 'Healthy 3-18 months old infants with mild to moderate diaper dermatitis.\n\nCeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '1.73', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Arms are combined for overall number of baseline participants. Due to the low number of subjects, data will not be analyzed and the arm assignment for the subjects was not determined.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Principal Investigator and sponsor agreed to termination.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-13', 'studyFirstSubmitDate': '2014-11-20', 'resultsFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-13', 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.', 'timeFrame': '14 days', 'description': 'For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.'}], 'secondaryOutcomes': [{'measure': 'Change in Physician Assessment Diaper Dermatitis Scores to Day 7', 'timeFrame': '7 days', 'description': 'For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.'}, {'measure': 'Parents/Caregivers Daily Scores Through Duration of the Study Period', 'timeFrame': '14 days', 'description': "Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level"}, {'measure': 'Assessment of Tolerability by the Infant', 'timeFrame': '14 days', 'description': "Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a VAS severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level"}, {'measure': 'Parent/Caregiver Rating of Satisfaction With Use of the Product', 'timeFrame': '14 days', 'description': 'Parents/caregivers will be given a questionnaire rating the use of the study products.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diaper Rash']}, 'descriptionModule': {'briefSummary': "This is a single-center, 1:1 randomized, double-blind, parallel-group, non-inferiority controlled trial to demonstrate non-inferiority of CeraVe Baby Diaper Rash Cream compared to Desitin Maximum Strength Original Paste when administered to children with diaper dermatitis who are between 3 months to 18 months of age. Parents/caregivers of subjects in both groups will administer the product with each diaper change throughout the course of the study period. Product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. Subjects will be assessed by the study doctor, parent/caregiver will be asked about any adverse effects. Parent/caregivers will also be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level. Parents/caregivers will also be given a questionnaire rating the use of the study products.", 'detailedDescription': "Visit 1 - Screening and Baseline Visit (Day 0) Subjects will be evaluated for study eligibility using inclusion and exclusion criteria. The study doctor will assess diaper dermatitis for inclusion and exclusion criteria and to verify mild to moderate severity. Once study eligibility has been confirmed, parental/guardian consent will be obtained. No washout period is necessary for this study.\n\nLocation of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Study products will be dispensed to parent/caregiver, along with instructions for administration. Parent/caregivers will also be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level. Parents/caregivers will be asked to complete the daily diary for each day of the study.\n\nVisit 2 (Day 7) Subjects will again be assessed by the study doctor. Parent/caregiver will be asked about any adverse effects in last 7 days.\n\nVisit 3 - End of study (Day 14) Subjects will again be assessed by the study doctor. Daily diaries and product will be collected at this time. Parent/caregiver will be asked about any adverse effects in last 7 days. Parents/caregivers will also be given a questionnaire rating the use of the study products."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children (except for diaper dermatitis) between 3 and 18 months of age\n* Wearing diapers 24 hours per day\n* Clinical irritant diaper dermatitis\n* Received a Diaper Dermatitis severity score of 1.0 to 2.0 by investigator at screening visit (mild-moderate severity)\n* Parent/caregiver will not change type or brand of diaper during the study, although the diaper type will be recorded\n* No alteration of current product usage for creams, lotions, ointments, powders, soap, laundry detergents, and fabric softeners\n* A parent or guardian of minors must sign the approved Institutional Review Board consent form prior to the conduct of any study-related procedures\n\nExclusion Criteria:\n\n* Illness within past 4 days before study enrollment or any medical condition that may affect risk of study participation\n* Does not wear diapers 24 hours per day or currently being toilet trained\n* Active diagnosis or history of dermatological conditions other than diaper rash that may affect study\n* Concomitant use of medications that may affect study (e.g., antifungal, topical steroid, or topical calcineurin inhibitor)\n* Previous allergic reaction or known sensitivity to ingredients in study agents'}, 'identificationModule': {'nctId': 'NCT02299206', 'briefTitle': 'CeraVe Cream Compared to Desitin Paste for Treating Diaper Dermatitis in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Randomized, Double-Blind, Parallel Group, Non-Inferiority Clinical Trial of CeraVe Baby Diaper Rash Cream Compared to Desitin Maximum Strength Original Paste for Management of Diaper Dermatitis in Infants', 'orgStudyIdInfo': {'id': 'ASP05012014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CeraVe Baby Diaper Rash Cream', 'description': 'Healthy 3-18 months old infants with mild to moderate diaper dermatitis.', 'interventionNames': ['Drug: CeraVe Baby Diaper Rash Cream']}, {'type': 'EXPERIMENTAL', 'label': 'Desitin Maximum Strength Original Paste', 'description': 'Healthy 3-18 months old infants with mild to moderate diaper dermatitis.', 'interventionNames': ['Drug: Desitin Maximum Strength Original Paste']}], 'interventions': [{'name': 'CeraVe Baby Diaper Rash Cream', 'type': 'DRUG', 'otherNames': ['CeraVe BDRC NDC Code: 0187-2221'], 'description': 'Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.', 'armGroupLabels': ['CeraVe Baby Diaper Rash Cream']}, {'name': 'Desitin Maximum Strength Original Paste', 'type': 'DRUG', 'otherNames': ['Desitin MSOP NDC Code: 58232-0721'], 'description': 'Parents/caregivers of subjects will administer Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.', 'armGroupLabels': ['Desitin Maximum Strength Original Paste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-2991', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Department of Dermatology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Lurie Children's Hospital Outpatient Clinic at Lincoln Park", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Amy Paller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Der,matology, Feinberg School of Medicine, Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair of Department of Dermatology, Professor of Pediatrics', 'investigatorFullName': 'Amy Paller', 'investigatorAffiliation': 'Northwestern University'}}}}