Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01375205
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2011-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D000090984', 'term': 'Ad26COVS1'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'simpsone@ohsu.edu', 'phone': '503-494-3968', 'title': 'Eric Simpson, MD, MCR', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the time informed consent is signed through the 24 month study follow-up telephone call.', 'eventGroups': [{'id': 'EG000', 'title': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.\n\nCetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.", 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 30, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.\n\nStandard of Care: Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.", 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 21, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Baby Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral exanthems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heat rash/miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diaper dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seborrheic Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unspecified Transient Rashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash to Vaccination/Drug Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritant Contact Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticarial Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Idiopathic Intracranial Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RSV and Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.\n\nCetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.\n\nStandard of Care: Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser."}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Around 28% of subjects enrolled were lost to follow-up by 12 months'}, {'type': 'SECONDARY', 'title': 'Percentage of High Emollient Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.\n\nCetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.\n\nStandard of Care: Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser."}], 'classes': [{'title': 'Percentage of high emollient use at 2 months', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '45.2', 'groupId': 'OG001'}]}]}, {'title': 'Percentage of high emollient use at 6 months', 'categories': [{'measurements': [{'value': '72.4', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}]}]}, {'title': 'Percentage of high emollient use at 12 months', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}]}]}, {'title': 'Percentage of high emollient use at 18 months', 'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}]}]}, {'title': 'Percentage of high emollient use at 24 months', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2, 6, 12, 18, and 24 months', 'description': 'Patient-reported adherence to the emollient regimen in the intervention group and the treatment group. High emollient use was defined as applying the intervention or control emollient five or more days per week.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Age at Onset of Eczema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.\n\nCetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.\n\nStandard of Care: Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '24'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through Month 24 Follow-up', 'description': 'Age of subject at onset of eczema', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Filaggrin Mutation Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.\n\nCetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.\n\nStandard of Care: Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser."}], 'classes': [{'categories': [{'title': 'Positive for Filaggrin Mutation', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Negative for Filaggrin Mutation', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 month visit', 'description': 'Filaggrin mutation status result', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed captures only those participants that completed 6 month filaggrin testing. Not all participants noted in the overall participant flow were able to complete filaggrin testing either due to study status (i.e., lost to follow up, withdrawn) or missed visit.'}, {'type': 'SECONDARY', 'title': 'Transepidermal Water Loss (TEWL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.\n\nCetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.\n\nStandard of Care: Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser."}], 'classes': [{'title': 'Average TEWL (g/[m2hr]) at 2 months', 'categories': [{'measurements': [{'value': '16.3', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Average TEWL (g/[m2hr]) at 6 months', 'categories': [{'measurements': [{'value': '15.9', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Average TEWL (g/[m2hr]) at 12 months', 'categories': [{'measurements': [{'value': '13.9', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '5.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 month, 6 month, and 12 month visits', 'description': 'Transepidermal water loss (TEWL) to measure skin barrier function', 'unitOfMeasure': '(g/[m2hr])', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed captures only those participants that completed TEWL testing at all time points. Not all participants noted in the overall participant flow were able to complete TEWL testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits.'}, {'type': 'SECONDARY', 'title': 'Skin Hydration (Skin Electrical Capacitance)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.\n\nCetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.\n\nStandard of Care: Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser."}], 'classes': [{'title': 'Average capacitance at 2 months', 'categories': [{'measurements': [{'value': '55.2', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '53.9', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Average capacitance at 6 months', 'categories': [{'measurements': [{'value': '51.8', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '52.1', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Average capacitance at 12 months', 'categories': [{'measurements': [{'value': '49.4', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '53.7', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 month, 6 month, and 12 month visits', 'description': 'Determination of stratum corneum hydration from the dorsal forearm', 'unitOfMeasure': 'farads', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed captures only those participants that completed skin hydration testing at all time points. Not all participants noted in the overall participant flow were able to complete skin hydration testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits.'}, {'type': 'SECONDARY', 'title': 'Skin pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.\n\nCetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.\n\nStandard of Care: Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser."}], 'classes': [{'title': 'Average pH at 2 months', 'categories': [{'measurements': [{'value': '5.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Average pH at 6 months', 'categories': [{'measurements': [{'value': '5.3', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Average pH at 12 months', 'categories': [{'measurements': [{'value': '5.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 month, 6 month, and 12 month visits', 'description': 'Skin pH, as measured using a pH probe', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed captures only those participants that completed Skin pH testing at all time points. Not all participants noted in the overall participant flow were able to complete Skin pH testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits.'}, {'type': 'POST_HOC', 'title': 'Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.\n\nCetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.\n\nStandard of Care: Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser."}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}, {'value': '31.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'description': 'Percentage of cumulative Atopic Dermatitis diagnosed by any MD at 24 Months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed captures only those participants still on study at 24 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.\n\nCetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."}, {'id': 'FG001', 'title': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.\n\nStandard of Care: Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.\n\nCetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser."}, {'id': 'BG001', 'title': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.\n\nStandard of Care: Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-30', 'studyFirstSubmitDate': '2011-06-15', 'resultsFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2011-06-16', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-22', 'studyFirstPostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months', 'timeFrame': '12 months', 'description': 'Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of High Emollient Use', 'timeFrame': '2, 6, 12, 18, and 24 months', 'description': 'Patient-reported adherence to the emollient regimen in the intervention group and the treatment group. High emollient use was defined as applying the intervention or control emollient five or more days per week.'}, {'measure': 'Age at Onset of Eczema', 'timeFrame': 'Baseline through Month 24 Follow-up', 'description': 'Age of subject at onset of eczema'}, {'measure': 'Filaggrin Mutation Status', 'timeFrame': '6 month visit', 'description': 'Filaggrin mutation status result'}, {'measure': 'Transepidermal Water Loss (TEWL)', 'timeFrame': '2 month, 6 month, and 12 month visits', 'description': 'Transepidermal water loss (TEWL) to measure skin barrier function'}, {'measure': 'Skin Hydration (Skin Electrical Capacitance)', 'timeFrame': '2 month, 6 month, and 12 month visits', 'description': 'Determination of stratum corneum hydration from the dorsal forearm'}, {'measure': 'Skin pH', 'timeFrame': '2 month, 6 month, and 12 month visits', 'description': 'Skin pH, as measured using a pH probe'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'skin care'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': "The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on babies' skin versus Johnson \\& Johnson baby lotion and skin cleanser.", 'detailedDescription': "Subjects will randomly be divided into a group using Cetaphil® Restoraderm® system or a group using Johnson \\& Johnson baby lotion and skin cleanser . At 3, 6, and 12 months non-invasive measurements of barrier function will be used to test the babies' skin. The procedures are as follows:\n\n* Transepidermal loss (TEWL - measures the water loss from the skin)\n* Skin electrical capacitance (measures how much water stays in the top layer of skin)\n* Skin pH (measures level of pH)\n* Skin microbiome analysis (skin swabs to check genetic code of skin bacteria)\n* Lipidomic and natural moisturizing factor analysis (measures lipids (oils) in the top layer of skin)\n\nBoth groups will be reminded to follow the instructions about general good skin care of infants. Subjects will be asked if they agree to provide a saliva sample. If yes, a saliva sample will be collected from the inside of the infant's cheek at the 6 month visit and will be shipped to the laboratory of Dr. Irwin McLean at the University of Dundee, where it will be tested for gene defects in the skin barrier that might trigger the development of eczema. Defects in the gene called filaggrin have been shown to increase the risk of developing eczema. The samples will be identified by a code to protect your infant's identity. The saliva samples will be stored only for this study, and then the sample will be destroyed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Weeks', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants up to three weeks of age born to mothers aged 18-45 years will be recruited for this study.\n* Infants must have a family history of asthma, eczema, or hayfever in at least one first-degree relative and be in otherwise good overall health.\n\nExclusion Criteria:\n\n* Preterm birth defined as birth prior to 37 weeks gestation\n* Major congenital anomaly\n* Hydrops fetalis\n* Significant dermatitis at birth not including seborrheic dermatitis on the scalp ("cradle cap")\n* Any immunodeficiency disorder\n* Any severe genetic skin disorder\n* Any other serious condition that would make the use of emollients inadvisable\n* Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess'}, 'identificationModule': {'nctId': 'NCT01375205', 'briefTitle': 'Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'Galderma Cetaphil Restoraderm'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.", 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Cetaphil Restoraderm', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.", 'interventionNames': ['Other: Cetaphil Restoraderm']}], 'interventions': [{'name': 'Cetaphil Restoraderm', 'type': 'OTHER', 'description': "Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.", 'armGroupLabels': ['Cetaphil Restoraderm']}, {'name': 'Standard of Care', 'type': 'OTHER', 'otherNames': ['Johnson&Johnson'], 'description': "Subjects will apply Johnson\\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\\&Johnson cleanser.", 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University Center for Health & Healing', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Eric Simpson, MD, MCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Galderma R&D', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., M.C.R.', 'investigatorFullName': 'Eric Simpson', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}