Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT00804193
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2008-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014008', 'term': 'Tinea Pedis'}], 'ancestors': [{'id': 'D014005', 'term': 'Tinea'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D005533', 'term': 'Foot Dermatoses'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jonathan.schwartz@perrigo.com', 'phone': '718-960-0119', 'title': 'Jonathan Schwartz', 'organization': 'Perrigo'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Test Product', 'description': 'Ciclopirox Olamine Topical Suspension', 'otherNumAtRisk': 220, 'otherNumAffected': 0, 'seriousNumAtRisk': 220, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference Product', 'description': 'Loprox® Topical Suspension 0.77%', 'otherNumAtRisk': 224, 'otherNumAffected': 0, 'seriousNumAtRisk': 224, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Vehicle Product', 'description': 'placebo of test product', 'otherNumAtRisk': 109, 'otherNumAffected': 0, 'seriousNumAtRisk': 109, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Perforated sigmoid colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Subarachnoid hemorrhage; MCA aneurysm; PCOM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Blood clots spleen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Seizures (transient ischaemic attack)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Right hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (7.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects in Each Treatment Group With Therapeutic Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Ciclopirox Olamine Topical Suspension'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Loprox® Topical Suspension 0.77%'}, {'id': 'OG002', 'title': 'Vehicle Product', 'description': 'placebo of test product'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '9', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '18.85', 'estimateComment': 'The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.', 'statisticalMethod': "Wald's method, Yates", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'statisticalComment': "CI calculated using Wald's method with Yates' continuity correction.", 'nonInferiorityComment': "90% CI was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% CI was contained within the interval -0.20 to +0.20 (-20% to +20%)."}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \\[KOH\\] wet mount negative and fungal culture negative) and Clinical Cure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Mycological Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Ciclopirox Olamine Topical Suspension'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Loprox® Topical Suspension 0.77%'}, {'id': 'OG002', 'title': 'Vehicle Product', 'description': 'placebo of test product'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1', 'ciLowerLimit': '-7.08', 'ciUpperLimit': '9.24', 'estimateComment': 'The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.', 'statisticalMethod': "Wald's method with Yates' continuity cor", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': "90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20)."}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Potassium hydroxide \\[KOH\\] wet mount negative and fungal culture negative', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Clinical Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product', 'description': 'Ciclopirox Olamine Topical Suspension'}, {'id': 'OG001', 'title': 'Reference Product', 'description': 'Loprox® Topical Suspension 0.77%'}, {'id': 'OG002', 'title': 'Vehicle Product', 'description': 'placebo of test product'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4', 'ciLowerLimit': '-4.60', 'ciUpperLimit': '14.24', 'estimateComment': 'The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.', 'statisticalMethod': "Wald's method Yates' continuity cor", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': "90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20)."}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': "Clinical Cure was defined as a signs and symptoms score of \\<1 for erythema; \\<1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Product', 'description': 'Ciclopirox Olamine Topical Suspension; the Test Product was applied treatment two times a day for 4 weeks'}, {'id': 'FG001', 'title': 'Reference Product', 'description': 'Loprox® Topical Suspension 0.77%; the Reference Product was applied treatment two times a day for 4 weeks'}, {'id': 'FG002', 'title': 'Vehicle Product', 'description': 'placebo of test product was applied treatment two times a day for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}, {'groupId': 'FG001', 'numSubjects': '224'}, {'groupId': 'FG002', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '180'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Lack of baseline fungus', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '553', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Product', 'description': 'Ciclopirox Olamine Topical Suspension'}, {'id': 'BG001', 'title': 'Reference Product', 'description': 'Loprox® Topical Suspension 0.77%'}, {'id': 'BG002', 'title': 'Vehicle Product', 'description': 'placebo of test product'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '16.0', 'groupId': 'BG000'}, {'value': '44.1', 'spread': '16.5', 'groupId': 'BG001'}, {'value': '47.7', 'spread': '16.5', 'groupId': 'BG002'}, {'value': '45.1', 'spread': '16.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '387', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '412', '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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '452', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '553', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 553}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2008-12-05', 'resultsFirstSubmitDate': '2012-09-10', 'studyFirstSubmitQcDate': '2008-12-05', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-11-19', 'studyFirstPostDateStruct': {'date': '2008-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects in Each Treatment Group With Therapeutic Success', 'timeFrame': '6 weeks', 'description': 'Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \\[KOH\\] wet mount negative and fungal culture negative) and Clinical Cure'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects With Mycological Cure', 'timeFrame': '6 weeks', 'description': 'Potassium hydroxide \\[KOH\\] wet mount negative and fungal culture negative'}, {'measure': 'Proportion of Subjects With Clinical Cure', 'timeFrame': '6 weeks', 'description': "Clinical Cure was defined as a signs and symptoms score of \\<1 for erythema; \\<1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tinea Pedis', 'Ciclopirox Olamine'], 'conditions': ['Tinea Pedis']}, 'descriptionModule': {'briefSummary': 'The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female at least 10 years of age, and otherwise healthy\n* Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis\n* In good health with no clinically significant disease that might have interfered with study evaluations\n* Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.\n\nExclusion Criteria:\n\n* History of hypersensitivity or allergy to ciclopirox\n* Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis\n* Had a history of dermatophyte infection unresponsive to antifungal treatment\n* Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study\n* Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk\n* Was unwilling to sign the informed consent\n* Female who was pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT00804193', 'briefTitle': 'Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Padagis LLC'}, 'officialTitle': 'A Double-blind, Randomized, Parallel-group, Vehicle-controlled, Multi-center Study to Evaluate the Safety and Clinical Equivalence of a Generic Ciclopirox Olamine Topical Suspension to Reference Ciclopirox Topical Suspension 0.77% in the Treatment of Tinea Pedis', 'orgStudyIdInfo': {'id': 'CPL-402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Product', 'description': 'Ciclopirox Olamine Topical Suspension', 'interventionNames': ['Drug: Ciclopirox Olamine Topical Suspension']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Product', 'description': 'Loprox® Topical Suspension 0.77%', 'interventionNames': ['Drug: Ciclopirox Topical Suspension 0.77%-Reference Product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Product', 'description': 'placebo of test product', 'interventionNames': ['Drug: Ciclopirox Olamine Topical Suspension-Placebo']}], 'interventions': [{'name': 'Ciclopirox Olamine Topical Suspension', 'type': 'DRUG', 'description': 'topical suspension', 'armGroupLabels': ['Test Product']}, {'name': 'Ciclopirox Topical Suspension 0.77%-Reference Product', 'type': 'DRUG', 'description': 'topical suspension', 'armGroupLabels': ['Reference Product']}, {'name': 'Ciclopirox Olamine Topical Suspension-Placebo', 'type': 'DRUG', 'description': 'topical suspension', 'armGroupLabels': ['Vehicle Product']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Padagis LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}