Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT01093469
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2010-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparing Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis
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': 'C530270', 'term': 'MAS063DP'}, {'id': 'C539259', 'term': 'EpiCeram'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adclark@wakehalth.edu', 'phone': '336-716-3775', 'title': 'Dr Alan Fleischer', 'organization': 'Wake Forest'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aquaphor Healing Ointment', 'description': 'Aquaphor Healing Ointment three times daily to atopic dermatitis', 'otherNumAtRisk': 13, 'otherNumAffected': 2, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Atopiclair Nonsteroidal Cream', 'description': 'Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis', 'otherNumAtRisk': 13, 'otherNumAffected': 2, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'EpiCream Skin Barrier Emulsion', 'description': 'EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis', 'otherNumAtRisk': 13, 'otherNumAffected': 2, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MRSA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening ATD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator Global Assessment of Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aquaphor Healing Ointment', 'description': 'Aquaphor Healing Ointment three times daily to atopic dermatitis'}, {'id': 'OG001', 'title': 'Atopiclair Nonsteroidal Cream', 'description': 'Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis'}, {'id': 'OG002', 'title': 'EpiCream Skin Barrier Emulsion', 'description': 'EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '2', 'spread': '1.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 21', 'description': 'This measures the overall response to treatment and quantifies disease on a 6 point scale from "completely clear" to "worsening of disease".0= Completely clear: except for possible residual hyperpigmentation, 1= Almost clear: very significant clearance (about 90%), 2 = Marked improvement: significant improvement (about 75%), 3= Moderate improvement: intermediate between slight and marked; representing about 50% improvements , 4= Slight improvement: some improvement (about 25%); however, significant disease remaining, 5 = No change from baseline, 6 = Worse', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aquaphor Healing Ointment', 'description': 'Aquaphor Healing Ointment three times daily to atopic dermatitis'}, {'id': 'FG001', 'title': 'Atopiclair Nonsteroidal Cream', 'description': 'Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis'}, {'id': 'FG002', 'title': 'EpiCream Skin Barrier Emulsion', 'description': 'EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Aquaphor Healing Ointment', 'description': 'Aquaphor Healing Ointment three times daily to atopic dermatitis'}, {'id': 'BG001', 'title': 'Atopiclair Nonsteroidal Cream', 'description': 'Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis'}, {'id': 'BG002', 'title': 'EpiCream Skin Barrier Emulsion', 'description': 'EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2010-03-24', 'resultsFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2010-03-24', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-11', 'studyFirstPostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Global Assessment of Improvement', 'timeFrame': 'Day 21', 'description': 'This measures the overall response to treatment and quantifies disease on a 6 point scale from "completely clear" to "worsening of disease".0= Completely clear: except for possible residual hyperpigmentation, 1= Almost clear: very significant clearance (about 90%), 2 = Marked improvement: significant improvement (about 75%), 3= Moderate improvement: intermediate between slight and marked; representing about 50% improvements , 4= Slight improvement: some improvement (about 25%); however, significant disease remaining, 5 = No change from baseline, 6 = Worse'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic Dermatitis', 'Wake Forest', 'Dermatology', 'Skin', 'Over-the-counter', 'Moisturizer', 'Children'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '21533301', 'type': 'DERIVED', 'citation': "Miller DW, Koch SB, Yentzer BA, Clark AR, O'Neill JR, Fountain J, Weber TM, Fleischer AB Jr. An over-the-counter moisturizer is as clinically effective as, and more cost-effective than, prescription barrier creams in the treatment of children with mild-to-moderate atopic dermatitis: a randomized, controlled trial. J Drugs Dermatol. 2011 May;10(5):531-7."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and cost effectiveness of Aquaphor Healing Ointment, Atopiclair and EpiCeram as a monotherapy in mild to moderate AD.\n\nThe investigators hypothesize that no statistical difference will exist in the efficacy between an over-the-counter moisturizer, Aquaphor Healing Ointment, compared to prescription devices Atopiclair and EpiCeram in treating mild to moderate AD. Therefore, Aquaphor will be most cost-effective than Atopiclair or EpiCeram.', 'detailedDescription': "The primary objective is to compare the efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and EpiCeram Skin Barrier Emulsion in children with mild to moderate atopic dermatitis. The secondary objective is to compare the cost-effectiveness of these products. A significant difference exists in the cost of these products; therefore, if our hypothesis is proved correct - that Aquaphor will be just as efficacious as the more expensive counterparts Atopiclair and EpiCeram - this could have a significant impact on the overall cost of treating atopic dermatitis.\n\nThis is a single center, investigator blinded, randomized, prospective controlled study of subjects with mild to moderate atopic dermatitis. The study is intended to compare the efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and the EpiCeram Skin Barrier Emulsion used three times a day in treating mild to moderate atopic dermatitis. All subjects will receive active study medication and will return to study center for efficacy and safety assessments at Days 7 and 21. Approximately 50 subjects will be enrolled in order to obtain 39 completed subjects that will be randomized 1:1:1 (13 to receive Aquaphor, 13 to receive Atopiclair and 13 to receive EpiCeram) according to standard randomization tables. Efficacy will be measured through Investigator's Global Assessment, BSA involvement, Investigator Global Assessment of Improvement, Eczema Area and Severity Index and 100-pt Visual Analog Score for pruritis. Subjects will complete a Subject Global Assessment of Improvement and a drug diary to monitor for compliance. Cost benefit analysis will be calculated as cost in dollars for change in outcome according to EASI, BSA and VAS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female with mild to moderate atopic dermatitis, 2-17 years of age, that agree to participate and provide written consent (and assent if applicable)\n* Have an investigator Global Assessment of mild to moderate atopic dermatitis (IGA rating of 2-3 in the Investigator Global Assessment)\n* Percentage of overall body surface area of involvement (BSA) must be \\> 1% and may include facial and intertriginous skin.\n\nExclusion Criteria:\n\n* Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.\n* Application or use within 2 weeks of baseline of topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome.\n* Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.\n* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating int he study (oral antihistamines will be allowed, so long as they are neither initiated nor discontinued during the course of this study)\n* Amount of disease involvement that would require \\>60gm of cream in a 1 week period\n* Subjects with known allergy or sensitivity to Aquaphor Healing Ointment, Atopiclair or EpiCeram or components therein.'}, 'identificationModule': {'nctId': 'NCT01093469', 'briefTitle': 'Comparing Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'An Investigator Blinded, Randomized, Controlled Study Comparing the Efficacy and Cost-Effectiveness of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream (MAS063DP) and EpiCeram Skin Barrier Emulsion in Children With Mild to Moderate Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'IRB00009130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aquaphor Healing Ointment', 'description': 'Aquaphor Healing Ointment three times daily to atopic dermatitis', 'interventionNames': ['Other: Aquaphor Healing Ointment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atopiclair Nonsteroidal Cream', 'description': 'Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis', 'interventionNames': ['Drug: Atopiclair Nonsteroidal Cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EpiCream Skin Barrier Emulsion', 'description': 'EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis', 'interventionNames': ['Drug: EpiCeram']}], 'interventions': [{'name': 'Atopiclair Nonsteroidal Cream', 'type': 'DRUG', 'otherNames': ['MAS063DP'], 'armGroupLabels': ['Atopiclair Nonsteroidal Cream']}, {'name': 'Aquaphor Healing Ointment', 'type': 'OTHER', 'armGroupLabels': ['Aquaphor Healing Ointment']}, {'name': 'EpiCeram', 'type': 'DRUG', 'otherNames': ['BRC-Cer'], 'armGroupLabels': ['EpiCream Skin Barrier Emulsion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Alan Fleischer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences Department of Dermatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}