Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT01214434
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2010-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Promiseb Topical Cream for Cradle Cap
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012628', 'term': 'Dermatitis, Seborrheic'}, {'id': 'C537005', 'term': 'Complement component 5 deficiency'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'product-complaints@promiuspharma.com', 'phone': '888 966-8766', 'title': 'Medical Information Center', 'organization': 'Promius Pharma, LLC'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Small number of subjects enrolled and analyzed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bland Emollient', 'description': 'Bland emollient : Eucerin cream twice daily', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Promiseb Topical Cream', 'description': 'Promiseb Topical Cream : topical non steroidal cream, twice daily', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Strep throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bland Emollient', 'description': 'Bland emollient : Eucerin cream twice daily'}, {'id': 'OG001', 'title': 'Promiseb Topical Cream', 'description': 'Promiseb Topical Cream : topical non steroidal cream, twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'end of treatment (Day 7 or 14)', 'description': 'IGA scored on scale of 0 (clear) to 4 (severe).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Excellent Overall Safety Score at End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bland Emollient', 'description': 'Bland emollient : Eucerin cream twice daily'}, {'id': 'OG001', 'title': 'Promiseb Topical Cream', 'description': 'Promiseb Topical Cream : topical non steroidal cream, twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment', 'description': 'The investigator will assess tolerance at Day 7 and Day 14 using an overall safety score of 0 to 3 defined as; Grade 0-No signs of irritation (excellent); Grade 1-Slight signs of irritation which resolved (Good); Grade 2-Clear signs of irritation (Fair); Grade 3-Patient discontinued due to irritation(Poor).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.'}, {'type': 'SECONDARY', 'title': 'Precent Reduction From Baseline for Scaling at End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bland Emollient', 'description': 'Bland emollient : Eucerin cream twice daily'}, {'id': 'OG001', 'title': 'Promiseb Topical Cream', 'description': 'Promiseb Topical Cream : topical non steroidal cream, twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '62', 'groupId': 'OG000'}, {'value': '90', 'spread': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.03', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to end of treatment (Day 7 or 14)', 'description': 'Scaling score on a scale of 0 (none) to 4 (severe).', 'unitOfMeasure': 'percent reduction from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline for Crusting at End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bland Emollient', 'description': 'Bland emollient : Eucerin cream twice daily'}, {'id': 'OG001', 'title': 'Promiseb Topical Cream', 'description': 'Promiseb Topical Cream : topical non steroidal cream, twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'spread': '22', 'groupId': 'OG000'}, {'value': '78', 'spread': '48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.6', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to end of treatment (Day 7 or 14)', 'description': 'Crusting scored on a scale of 0 (none) to 4 (severe).', 'unitOfMeasure': 'percent reduction from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline for Erythema at End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bland Emollient', 'description': 'Bland emollient : Eucerin cream twice daily'}, {'id': 'OG001', 'title': 'Promiseb Topical Cream', 'description': 'Promiseb Topical Cream : topical non steroidal cream, twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'spread': '43', 'groupId': 'OG000'}, {'value': '89', 'spread': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=.24', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to end of treatment (Day 7 or 14)', 'description': 'Erythema scored on scale of 0 (none) to 4 (severe).', 'unitOfMeasure': 'percent reduction from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline for Oiliness at End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bland Emollient', 'description': 'Bland emollient : Eucerin cream twice daily'}, {'id': 'OG001', 'title': 'Promiseb Topical Cream', 'description': 'Promiseb Topical Cream : topical non steroidal cream, twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'spread': '23', 'groupId': 'OG000'}, {'value': '90', 'spread': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.8', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to end of treatment (Day 7 or 14)', 'description': 'Oiliness scored on a scale of 0 (none) to 4 (severe).', 'unitOfMeasure': 'percent reduction from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bland Emollient', 'description': 'Bland emollient : Eucerin cream twice daily'}, {'id': 'FG001', 'title': 'Promiseb Topical Cream', 'description': 'Promiseb Topical Cream : topical non steroidal cream, twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Site error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bland Emollient', 'description': 'Bland emollient : Eucerin cream twice daily'}, {'id': 'BG001', 'title': 'Promiseb Topical Cream', 'description': 'Promiseb Topical Cream : topical non steroidal cream, twice daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '42', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '0.8', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '1.0', 'spread': '2.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2010-09-28', 'resultsFirstSubmitDate': '2013-07-08', 'studyFirstSubmitQcDate': '2010-10-01', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-09-17', 'studyFirstPostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).', 'timeFrame': 'end of treatment (Day 7 or 14)', 'description': 'IGA scored on scale of 0 (clear) to 4 (severe).'}, {'measure': 'Number of Participants With Excellent Overall Safety Score at End of Treatment.', 'timeFrame': 'End of treatment', 'description': 'The investigator will assess tolerance at Day 7 and Day 14 using an overall safety score of 0 to 3 defined as; Grade 0-No signs of irritation (excellent); Grade 1-Slight signs of irritation which resolved (Good); Grade 2-Clear signs of irritation (Fair); Grade 3-Patient discontinued due to irritation(Poor).'}], 'secondaryOutcomes': [{'measure': 'Precent Reduction From Baseline for Scaling at End of Treatment.', 'timeFrame': 'From Baseline to end of treatment (Day 7 or 14)', 'description': 'Scaling score on a scale of 0 (none) to 4 (severe).'}, {'measure': 'Percent Reduction From Baseline for Crusting at End of Treatment.', 'timeFrame': 'From Baseline to end of treatment (Day 7 or 14)', 'description': 'Crusting scored on a scale of 0 (none) to 4 (severe).'}, {'measure': 'Percent Reduction From Baseline for Erythema at End of Treatment.', 'timeFrame': 'From Baseline to end of treatment (Day 7 or 14)', 'description': 'Erythema scored on scale of 0 (none) to 4 (severe).'}, {'measure': 'Percent Reduction From Baseline for Oiliness at End of Treatment.', 'timeFrame': 'From Baseline to end of treatment (Day 7 or 14)', 'description': 'Oiliness scored on a scale of 0 (none) to 4 (severe).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cradle Cap', 'Infantile seborrheic Dermatitis'], 'conditions': ['Cradle Cap', 'Infantile Seborrheic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in cradle cap.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of cradle cap\n* Must be at least 30 days old\n* Must be in good health as determined by investigator\n* Naive to prior cradle cap therapy (may have used mineral, olive oils)\n\nExclusion Criteria:\n\n* Known food, topical product or medicinal allergies.\n* Prior use of corticosteroids, antifungals or keratolytics for Cradle Cap\n* Weighing less than 7 lbs'}, 'identificationModule': {'nctId': 'NCT01214434', 'briefTitle': 'Promiseb Topical Cream for Cradle Cap', 'organization': {'class': 'INDUSTRY', 'fullName': 'Promius Pharma, LLC'}, 'officialTitle': 'A Double Blind, Placebo-Controlled, Pilot Study to Estimate the Efficacy and Tolerability of Twice Daily Promiseb Topical Cream in Pediatric Subjects With Cradle Cap (Seborrheic Dermatitis)', 'orgStudyIdInfo': {'id': 'PSC0903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Promiseb Topical Cream', 'interventionNames': ['Device: Promiseb Topical Cream']}, {'type': 'SHAM_COMPARATOR', 'label': 'Bland emollient', 'interventionNames': ['Other: Bland emollient']}], 'interventions': [{'name': 'Promiseb Topical Cream', 'type': 'DEVICE', 'description': 'topical non steroidal cream, twice daily', 'armGroupLabels': ['Promiseb Topical Cream']}, {'name': 'Bland emollient', 'type': 'OTHER', 'description': 'Eucerin cream twice daily', 'armGroupLabels': ['Bland emollient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwich Pediatric Group', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Derm Research', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '07101', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Joanne M Fraser, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Promius Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Promius Pharma, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}