Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-01 @ 9:31 PM
Study NCT ID:
NCT04724967
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2021-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CeraVe Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D048909', 'term': 'Diabetes Complications'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rkirsner@med.miami.edu', 'phone': '305-689-2646', 'title': 'Robert Kirsner', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '33 days', 'eventGroups': [{'id': 'EG000', 'title': 'CeraVe Group', 'description': 'Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.\n\nCeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days\n\nCeraVe Moisturizing Cream: topical cream applied twice a day for 28 days', 'otherNumAtRisk': 528, 'deathsNumAtRisk': 528, 'otherNumAffected': 0, 'seriousNumAtRisk': 528, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CeraVe Group', 'description': 'Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.\n\nCeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days\n\nCeraVe Moisturizing Cream: topical cream applied twice a day for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 33 days', 'description': 'As evaluated by treating physician as possibly or probably related to intervention', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CeraVe Group', 'description': 'Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.\n\nCeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days\n\nCeraVe Moisturizing Cream: topical cream applied twice a day for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 33 days', 'description': 'As evaluated by treating physician as possibly or probably related to intervention', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants at Each GAIS Grading Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CeraVe Group', 'description': 'Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.\n\nCeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days\n\nCeraVe Moisturizing Cream: topical cream applied twice a day for 28 days'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 33 days', 'description': 'Physician-assessed number of participants at each Global Aesthetic Improvement Scale (GAIS). GAIS has gradings of very much improved, much improved, improved, no change and worse. A grading of worse means the least aesthetic improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants at Each Dry Skin Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CeraVe Group', 'description': 'Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.\n\nCeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days\n\nCeraVe Moisturizing Cream: topical cream applied twice a day for 28 days'}], 'classes': [{'title': 'Roughness/scaling - none', 'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}]}]}, {'title': 'Roughness/scaling - Almost None', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}]}]}, {'title': 'Roughness/scaling - Mild', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Roughness/scaling - Moderate', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Roughness/scaling - Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Itchiness - None', 'categories': [{'measurements': [{'value': '386', 'groupId': 'OG000'}]}]}, {'title': 'Itchiness - Almost None', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}]}]}, {'title': 'Itchiness - Mild', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Itchiness - Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Itchiness - Severe', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Pain - None', 'categories': [{'measurements': [{'value': '494', 'groupId': 'OG000'}]}]}, {'title': 'Pain - Almost', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Pain - Mild', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Pain - Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pain - Severe', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Erythema - None', 'categories': [{'measurements': [{'value': '409', 'groupId': 'OG000'}]}]}, {'title': 'Erythema - Almost None', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Erythema - Mild', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Erythema - Moderate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Erythema - Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fissures - None', 'categories': [{'measurements': [{'value': '408', 'groupId': 'OG000'}]}]}, {'title': 'Fissures - Almost None', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}]}]}, {'title': 'Fissures - Mild', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Fissures - Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fissures - Severe', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 33 days', 'description': 'Physician-assessed number of participants at each Dry Skin Scale. Scales will be evaluated for each of the following conditions: roughness/scaling, itch, pain, erythema and fissures. Each condition will be scored from 0 (none), 1 (almost none), 2 (mild), 3 (moderate) to 4 (severe).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CeraVe Group', 'description': 'Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.\n\nCeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days\n\nCeraVe Moisturizing Cream: topical cream applied twice a day for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '528'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '528'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CeraVe Group', 'description': 'Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.\n\nCeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days\n\nCeraVe Moisturizing Cream: topical cream applied twice a day for 28 days'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '57.8', 'spread': '12.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '327', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '201', '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.'}, {'title': 'Diabetes mellitus type', 'classes': [{'title': 'Type 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}]}]}, {'title': 'Type 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '436', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2020-07-24', 'size': 588836, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-18T14:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 528}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2021-01-21', 'resultsFirstSubmitDate': '2022-07-15', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-29', 'studyFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Reporting Adverse Events (AE)', 'timeFrame': 'Up to 33 days', 'description': 'As evaluated by treating physician as possibly or probably related to intervention'}, {'measure': 'Number of Participants at Each GAIS Grading Scale', 'timeFrame': 'At 33 days', 'description': 'Physician-assessed number of participants at each Global Aesthetic Improvement Scale (GAIS). GAIS has gradings of very much improved, much improved, improved, no change and worse. A grading of worse means the least aesthetic improvement.'}, {'measure': 'Number of Participants at Each Dry Skin Scale', 'timeFrame': 'At 33 days', 'description': 'Physician-assessed number of participants at each Dry Skin Scale. Scales will be evaluated for each of the following conditions: roughness/scaling, itch, pain, erythema and fissures. Each condition will be scored from 0 (none), 1 (almost none), 2 (mild), 3 (moderate) to 4 (severe).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cutaneous complication of DM'], 'conditions': ['Diabetes Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of the CeraVe Diabetic Skin Line for the improvement of skin condition in patients with diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men or women between the ages of 18 and 75 years of age.\n2. Willing to provide written informed consent.\n3. A diagnosis of diabetes mellitus (DM).\n4. DM-related skin changes classified into one or more of the following four categories: i) skin lesions associated with DM; ii) infections; iii) cutaneous manifestations of DM complications; iv) skin reaction to DM treatment.\n\nExclusion Criteria:\n\n1. History of allergy, anaphylaxis or hypersensitivity to any of the ingredients in CeraVe Hydrating Cleanser or Moisturizing Cream\n2. History of allergic contact dermatitis secondary to cleansers or moisturizers.\n3. Has a heightened immune response to common allergens, especially inhaled, topical or food allergens (atopy).\n4. Has any clinical manifestation in the treatment are(s) or other disorders that, in the investigator's opinion, may affect assessments or the study products.\n5. Inability to attend all study visits and follow treatment regimen."}, 'identificationModule': {'nctId': 'NCT04724967', 'briefTitle': 'CeraVe Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Clinical Evaluation of CeraVe Hydrating Cleanser and Moisturizing Cream for the Improvement of Skin Condition in Patients With Diabetes Mellitus (DM) Related Skin Changes', 'orgStudyIdInfo': {'id': '20201149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CeraVe Group', 'description': 'Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.', 'interventionNames': ['Drug: CeraVe Hydrating Cleanser', 'Drug: CeraVe Moisturizing Cream']}], 'interventions': [{'name': 'CeraVe Hydrating Cleanser', 'type': 'DRUG', 'description': 'topical cleanser applied twice a day for 28 days', 'armGroupLabels': ['CeraVe Group']}, {'name': 'CeraVe Moisturizing Cream', 'type': 'DRUG', 'description': 'topical cream applied twice a day for 28 days', 'armGroupLabels': ['CeraVe Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Robert Kirsner, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'CeraVe', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert S. Kirsner', 'investigatorAffiliation': 'University of Miami'}}}}