Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT00693693
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2008-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With 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': 'C007975', 'term': 'hydrocortisone-17-butyrate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sfeldman@wfubmc.edu', 'phone': '336-716-3775', 'title': 'Steven Feldman, MD, PhD', 'organization': 'Wake Forest University Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Topical Hydrocortisone 17-butyrate 0.1% Cream', 'description': 'topical hydrocortisone 17-butyrate 0.1% cream applied twice daily', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Topical Hydrocortisone 17-butyrate 0.1% Ointment', 'description': 'topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Topical Hydrocortisone 17-butyrate 0.1% Lipocream', 'description': 'topical hydrocortisone 17-butyrate 0.1% lipocream applied twice daily', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adherence to Locoid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cream', 'description': 'topical hydrocortisone 17-butyrate 0.1% cream applied twice daily to all areas of atopic dermatitis'}, {'id': 'OG001', 'title': 'Ointment', 'description': 'topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily to all areas of atopic dermatitis'}, {'id': 'OG002', 'title': 'Lipocream', 'description': 'topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily to all areas of atopic dermatitis'}], 'classes': [{'categories': [{'measurements': [{'value': '.55', 'spread': '.07', 'groupId': 'OG000'}, {'value': '.60', 'spread': '.07', 'groupId': 'OG001'}, {'value': '.50', 'spread': '.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ointment', 'description': 'topical hydrocortisone 17-butyrate 0.1% preparation ointment'}, {'id': 'FG001', 'title': 'Lipocream', 'description': 'topical hydrocortisone 17-butyrate 0.1% preparation lipocream'}, {'id': 'FG002', 'title': 'Cream', 'description': 'topical hydrocortisone 17-butyrate 0.1% preparation cream'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from IRB approved advertising and the Dermatology Clinic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cream', 'description': 'topical hydrocortisone 17-butyrate 0.1% cream applied twice daily'}, {'id': 'BG001', 'title': 'Ointment', 'description': 'topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily'}, {'id': 'BG002', 'title': 'Lipocream', 'description': 'topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '25', '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': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2008-06-05', 'resultsFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2008-06-06', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-27', 'studyFirstPostDateStruct': {'date': '2008-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to Locoid', 'timeFrame': '2 weeks', 'description': 'Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.', 'detailedDescription': "An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (\\>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software.\n\nThe study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions.\n\nAdherence will be measured by MEMs cap."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥ 18 years of age.\n* Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria. (2 or 3 on severity scale)\n* Subjects must have \\>5% TBSA and \\<30% to be enrolled.\n* Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.\n\nExclusion Criteria:\n\n* Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the subject.\n* Inability to complete all study-related visits.\n* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.\n* Requiring \\>130 gm of cream in a 2 week period.\n* Having facial or groin involvement of their disease.\n* Pregnant women and women who are breast feeding are to be excluded. Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.'}, 'identificationModule': {'nctId': 'NCT00693693', 'briefTitle': 'Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'IRB00000702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cream-', 'description': 'topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis', 'interventionNames': ['Drug: hydrocortisone 17-butyrate 0.1% Cream preparation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ointment', 'description': 'topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis', 'interventionNames': ['Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lipocream', 'description': 'topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis', 'interventionNames': ['Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation']}], 'interventions': [{'name': 'hydrocortisone 17-butyrate 0.1% Cream preparation', 'type': 'DRUG', 'otherNames': ['Locoid'], 'description': 'Apply medication twice a day to affected areas of atopic dermatitis', 'armGroupLabels': ['Cream-']}, {'name': 'hydrocortisone 17-butyrate 0.1% Ointment preparation', 'type': 'DRUG', 'otherNames': ['locoid'], 'description': 'Apply medication twice a day to affected areas of atopic dermatitis', 'armGroupLabels': ['Ointment']}, {'name': 'hydrocortisone 17-butyrate 0.1% Lipocream preparation', 'type': 'DRUG', 'otherNames': ['locoid'], 'description': 'Apply medication twice a day to affected areas of atopic dermatitis', 'armGroupLabels': ['Lipocream']}]}, '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': 'Steve Feldman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}