Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-09 @ 6:13 AM
Study NCT ID:
NCT04155203
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016712', 'term': 'Mupirocin'}], 'ancestors': [{'id': 'D004852', 'term': 'Epoxy Compounds'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jonathan.schwartz@padagis.com', 'phone': '929-502-7291', 'title': 'Jonathan Schwartz', 'organization': 'Padagis'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 to Day 17', 'eventGroups': [{'id': 'EG000', 'title': 'Perrigo Active', 'description': 'Mupirocin Calcium: mupirocin cream', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 0, 'seriousNumAtRisk': 219, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference Active', 'description': 'Mupirocin Calcium: Reference mupirocin cream', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 0, 'seriousNumAtRisk': 219, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Vehicle Control', 'description': 'Vehicle: vehicle control cream', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 0, 'seriousNumAtRisk': 219, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'cellulitis', 'notes': 'Cellulitis and abscess of right lower extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Perrigo Active', 'description': 'Mupirocin Calcium: mupirocin cream'}, {'id': 'OG001', 'title': 'Reference Active', 'description': 'Mupirocin Calcium: Reference mupirocin cream'}, {'id': 'OG002', 'title': 'Vehicle Control', 'description': 'Vehicle: vehicle control cream'}], 'classes': [{'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'equivalence ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.97', 'ciLowerLimit': '-8.19', 'ciUpperLimit': '2.70', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The primary efficacy endpoint was the proportion of subjects in each treatment group with clinical cure, defined as a SIRS score of 0 for all signs and symptoms at Visit 4/Follow-up (7 days after the end of treatment).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Perrigo Active', 'description': 'Mupirocin Calcium: mupirocin cream'}, {'id': 'FG001', 'title': 'Reference Active', 'description': 'Mupirocin Calcium: Reference mupirocin cream'}, {'id': 'FG002', 'title': 'Vehicle Control', 'description': 'Vehicle: vehicle control cream'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}, {'groupId': 'FG001', 'numSubjects': '219'}, {'groupId': 'FG002', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '184'}, {'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '54'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}, {'value': '657', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Perrigo Active', 'description': 'Mupirocin Calcium: mupirocin cream'}, {'id': 'BG001', 'title': 'Reference Active', 'description': 'Mupirocin Calcium: Reference mupirocin cream'}, {'id': 'BG002', 'title': 'Vehicle Control', 'description': 'Vehicle: vehicle control cream'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.58', 'spread': '16.924', 'groupId': 'BG000'}, {'value': '20.81', 'spread': '16.963', 'groupId': 'BG001'}, {'value': '21.75', 'spread': '17.089', 'groupId': 'BG002'}, {'value': '21.38', 'spread': '16.992', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 18 years old', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '297', 'groupId': 'BG003'}]}]}, {'title': '18 to 63 years old', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '348', 'groupId': 'BG003'}]}]}, {'title': '64 to 75 years old', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '290', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '367', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}, {'value': '654', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', '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': '102', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '306', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '285', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-25', 'size': 2080883, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-12T16:44', 'hasProtocol': True}, {'date': '2021-02-24', 'size': 2515836, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-12T16:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 657}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'dispFirstSubmitDate': '2022-05-23', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2019-11-04', 'dispFirstSubmitQcDate': '2022-05-23', 'resultsFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2019-11-05', 'dispFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-12', 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms)', 'timeFrame': '18 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Secondarily Infected Traumatic Skin Lesions']}, 'descriptionModule': {'briefSummary': "To compare the safety and efficacy of Perrigo's product to an FDA approved product, and to Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or non-pregnant females aged 18 months or older.\n2. Must have a secondarily infected traumatic skin lesion such as a laceration, sutured wound, or abrasion.\n3. Must have a positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from the secondarily infected traumatic skin lesion.\n4. Must have a positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion.\n5. Must have a Skin Infection Rating Scale (SIRS) total score for the secondarily infected traumatic skin lesion of at least 8 at baseline.\n6. Must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, and be able to complete the study.\n7. Must be in general good health and free from any clinically significant disease, other than secondarily infected traumatic skin lesion(s), that might interfere with the study evaluations.\n\nExclusion Criteria:\n\n1. Subjects who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.\n2. Presence of any dermatological disorder that may interfere with evaluation of the subject's secondarily infected traumatic skin lesion(s).\n3. Presence of bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic.\n4. Presence of secondarily infected bite or puncture wound.\n5. Presence of systemic signs or symptoms of infection (fever defined as an oral temperature greater than 101°F or 38.3°C).\n6. Requirement for surgical intervention for treatment of the infection prior to study entry.\n7. Presence of cutaneous herpes simplex infections.\n8. Use of any topical corticosteroid, topical antibiotic, or topical antifungal, on the secondarily infected target lesion, within 48 hours prior to Visit 1/Day 1.\n9. Use of systemic antibiotics or systemic corticosteroids within 7 days of Visit 1/Day 1.\n10. Primary or secondary immunodeficiency.\n11. Diagnosed Diabetes Mellitus (controlled or uncontrolled).\n12. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments.\n13. History of hypersensitivity or allergy to mupirocin and/or any ingredient in the study medication.\n14. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.\n15. Subjects who, in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study."}, 'identificationModule': {'nctId': 'NCT04155203', 'briefTitle': "To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions", 'organization': {'class': 'INDUSTRY', 'fullName': 'Padagis LLC'}, 'officialTitle': "Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Mupirocin Cream to A Reference Manufacturer's Mupirocin Cream and to Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions", 'orgStudyIdInfo': {'id': 'PRG-NY-19-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perrigo active', 'interventionNames': ['Drug: Mupirocin Calcium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Active', 'interventionNames': ['Drug: Mupirocin Calcium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle control', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'Mupirocin Calcium', 'type': 'DRUG', 'description': 'mupirocin cream', 'armGroupLabels': ['Perrigo active']}, {'name': 'Mupirocin Calcium', 'type': 'DRUG', 'description': 'Reference mupirocin cream', 'armGroupLabels': ['Reference Active']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'vehicle control cream', 'armGroupLabels': ['Vehicle control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Research Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Padagis LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}