Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-31 @ 2:14 PM
Study NCT ID:
NCT01712360
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2012-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014008', 'term': 'Tinea Pedis'}, {'id': 'D000084002', 'term': 'Tinea Cruris'}], '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'}, {'id': 'D007402', 'term': 'Intertrigo'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C029178', 'term': 'naftifine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ashlee.Duncan@merz.com', 'phone': '984-222-6040', 'title': 'Ashlee Duncan', 'organization': 'Merz North America, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'NAFT500 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (pediatric): Applied to both feet and groin area', 'otherNumAtRisk': 22, 'otherNumAffected': 4, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NAFT600 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (pediatric): Applied to both feet only', 'otherNumAtRisk': 22, 'otherNumAffected': 2, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'NAFT500 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (adult): Applied to both feet and groin area', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'NAFT600 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (adult): Applied to both feet', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NAFT500 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (pediatric): Applied to both feet and groin area'}, {'id': 'OG001', 'title': 'NAFT600 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (pediatric): Applied to both feet only'}, {'id': 'OG002', 'title': 'NAFT500 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (adult): Applied to both feet and groin area'}, {'id': 'OG003', 'title': 'NAFT600 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (adult): Applied to both feet'}], 'classes': [{'title': 'AUC0-24 Day 1, Single Dose', 'categories': [{'measurements': [{'value': '138262.2', 'spread': '50.2', 'groupId': 'OG000'}, {'value': '15890.1', 'spread': '211.6', 'groupId': 'OG001'}, {'value': '68634.2', 'spread': '95.4', 'groupId': 'OG002'}, {'value': '17213.9', 'spread': '88.1', 'groupId': 'OG003'}]}]}, {'title': 'AUCτ,ss Day 14 Multiple Dose', 'categories': [{'measurements': [{'value': '192485.4', 'spread': '74.9', 'groupId': 'OG000'}, {'value': '60038.5', 'spread': '131.1', 'groupId': 'OG001'}, {'value': '124596.0', 'spread': '49.9', 'groupId': 'OG002'}, {'value': '72849.8', 'spread': '71.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 14', 'description': 'Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:\n\n\\- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.\n\nVariables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:\n\n\\- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PKS), defined as the subset of subjects in the safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.'}, {'type': 'SECONDARY', 'title': 'Efficacy Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NAFT500 (Pediatric, Foot)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (pediatric): Applied to both feet and groin area'}, {'id': 'OG001', 'title': 'NAFT500 (Adult, Foot)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (adult): Applied to both feet and groin area'}, {'id': 'OG002', 'title': 'NAFT500 (Pediatric, Groin)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (pediatric): Applied to both feet and groin area'}, {'id': 'OG003', 'title': 'NAFT500 (Adult, Groin)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (adult): Applied to both feet and groin area'}, {'id': 'OG004', 'title': 'NAFT600 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (pediatric): Applied to both feet only'}, {'id': 'OG005', 'title': 'NAFT600 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (adult): Applied to both feet'}], 'classes': [{'title': 'Complete Cure', 'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000', 'lowerLimit': '39.5', 'upperLimit': '76.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '63.6', 'groupId': 'OG002', 'lowerLimit': '43.9', 'upperLimit': '80.4'}, {'value': '16.7', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '58.2'}, {'value': '27.3', 'groupId': 'OG004', 'lowerLimit': '12.6', 'upperLimit': '46.8'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Treatment Effectiveness', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '43.9', 'upperLimit': '80.4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '63.6', 'groupId': 'OG002', 'lowerLimit': '43.9', 'upperLimit': '80.4'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '15.3', 'upperLimit': '84.7'}, {'value': '54.5', 'groupId': 'OG004', 'lowerLimit': '35.3', 'upperLimit': '72.9'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '65.7'}]}]}, {'title': 'Mycological Cure', 'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000', 'lowerLimit': '48.5', 'upperLimit': '84.0'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '58.2'}, {'value': '72.7', 'groupId': 'OG002', 'lowerLimit': '53.2', 'upperLimit': '87.4'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '27.1', 'upperLimit': '93.7'}, {'value': '63.6', 'groupId': 'OG004', 'lowerLimit': '43.9', 'upperLimit': '80.4'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '65.7'}]}]}, {'title': 'Clinical Success', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '74.1', 'upperLimit': '98.4'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '27.1', 'upperLimit': '93.7'}, {'value': '90.9', 'groupId': 'OG002', 'lowerLimit': '74.1', 'upperLimit': '98.4'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '27.1', 'upperLimit': '93.7'}, {'value': '81.8', 'groupId': 'OG004', 'lowerLimit': '63.1', 'upperLimit': '93.5'}, {'value': '80', 'groupId': 'OG005', 'lowerLimit': '34.3', 'upperLimit': '99.0'}]}]}, {'title': 'Clinical Cure', 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000', 'lowerLimit': '63.1', 'upperLimit': '93.5'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '58.2'}, {'value': '81.8', 'groupId': 'OG002', 'lowerLimit': '63.1', 'upperLimit': '93.5'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '6.3', 'upperLimit': '72.9'}, {'value': '40.9', 'groupId': 'OG004', 'lowerLimit': '23.3', 'upperLimit': '60.5'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '65.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).\n\nEfficacy variables to be analyzed:\n\n* Complete cure\n* Treatment effectiveness\n* Mycological cure\n* Clinical success\n* Clinical cure', 'unitOfMeasure': 'Percentage (%) of subjects (90% CI)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.'}, {'type': 'PRIMARY', 'title': 'Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NAFT500 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (pediatric): Applied to both feet and groin area'}, {'id': 'OG001', 'title': 'NAFT600 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (pediatric): Applied to both feet only'}, {'id': 'OG002', 'title': 'NAFT500 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (adult): Applied to both feet and groin area'}, {'id': 'OG003', 'title': 'NAFT600 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (adult): Applied to both feet'}], 'classes': [{'title': 'Cmax Day 1, Single Dose', 'categories': [{'measurements': [{'value': '9213.35', 'spread': '48.4', 'groupId': 'OG000'}, {'value': '1397.77', 'spread': '153.8', 'groupId': 'OG001'}, {'value': '3983.34', 'spread': '83.0', 'groupId': 'OG002'}, {'value': '1741.02', 'spread': '69.2', 'groupId': 'OG003'}]}]}, {'title': 'Cmax, SS Day 14 Multiple Dose', 'categories': [{'measurements': [{'value': '12727.36', 'spread': '67.2', 'groupId': 'OG000'}, {'value': '3813.38', 'spread': '153.9', 'groupId': 'OG001'}, {'value': '6826.70', 'spread': '51.3', 'groupId': 'OG002'}, {'value': '3538.84', 'spread': '73.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 14', 'description': 'Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:\n\n\\- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.\n\nVariables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:\n\n\\- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PKS), defined as the subset of subjects in safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.'}, {'type': 'SECONDARY', 'title': 'Efficacy Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NAFT500 (Pediatric, Foot)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (pediatric): Applied to both feet and groin area'}, {'id': 'OG001', 'title': 'NAFT500 (Adult, Foot)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (adult): Applied to both feet and groin area'}, {'id': 'OG002', 'title': 'NAFT500 (Pediatric, Groin)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (pediatric): Applied to both feet and groin area'}, {'id': 'OG003', 'title': 'NAFT500 (Adult, Groin)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (adult): Applied to both feet and groin area'}, {'id': 'OG004', 'title': 'NAFT600 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (pediatric): Applied to both feet only'}, {'id': 'OG005', 'title': 'NAFT600 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (adult): Applied to both feet'}], 'classes': [{'title': 'Excellent Improvement', 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '86.4', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}, {'value': '54.5', 'groupId': 'OG004'}, {'value': '20.0', 'groupId': 'OG005'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}, {'value': '13.6', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '36.4', 'groupId': 'OG004'}, {'value': '60.0', 'groupId': 'OG005'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '4.5', 'groupId': 'OG004'}, {'value': '20.0', 'groupId': 'OG005'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).\n\nEfficacy variables to be analyzed:\n\n\\- Subject satisfaction', 'unitOfMeasure': 'Percentage (%) of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NAFT500 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (pediatric): Applied to both feet and groin area'}, {'id': 'FG001', 'title': 'NAFT600 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (pediatric): Applied to both feet only'}, {'id': 'FG002', 'title': 'NAFT500 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (adult): Applied to both feet and groin area'}, {'id': 'FG003', 'title': 'NAFT600 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (adult): Applied to both feet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'NAFT500 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (pediatric): Applied to both feet and groin area'}, {'id': 'BG001', 'title': 'NAFT600 (Pediatric)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (pediatric): Applied to both feet only'}, {'id': 'BG002', 'title': 'NAFT500 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT500 (adult): Applied to both feet and groin area'}, {'id': 'BG003', 'title': 'NAFT600 (Adult)', 'description': 'Topical once a day for two weeks\n\nNAFT600 (adult): Applied to both feet'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '14.7', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '38.7', 'spread': '6.5', 'groupId': 'BG002'}, {'value': '31.7', 'spread': '11.2', 'groupId': 'BG003'}, {'value': '19.1', 'spread': '9.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'Honduras', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'Dominican Republic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set which is the subset of subjects who have been exposed to the study medication at least once'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-03', 'studyFirstSubmitDate': '2012-10-16', 'resultsFirstSubmitDate': '2016-04-14', 'studyFirstSubmitQcDate': '2012-10-19', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-03', 'studyFirstPostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose', 'timeFrame': 'Day 1 and Day 14', 'description': 'Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:\n\n\\- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.\n\nVariables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:\n\n\\- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state'}, {'measure': 'Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose', 'timeFrame': 'Day 1 and Day 14', 'description': 'Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:\n\n\\- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.\n\nVariables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:\n\n\\- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).'}], 'secondaryOutcomes': [{'measure': 'Efficacy Variables', 'timeFrame': 'Day 28', 'description': 'Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).\n\nEfficacy variables to be analyzed:\n\n* Complete cure\n* Treatment effectiveness\n* Mycological cure\n* Clinical success\n* Clinical cure'}, {'measure': 'Efficacy Variables', 'timeFrame': 'Day 28', 'description': 'Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).\n\nEfficacy variables to be analyzed:\n\n\\- Subject satisfaction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tinea Pedis', 'Tinea Cruris', 'Athlete foot', 'Jock itch'], 'conditions': ['Tinea Pedis', 'Tinea Cruris']}, 'descriptionModule': {'briefSummary': "This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.", 'detailedDescription': 'Study population, diagnosis, and main criteria for inclusion:\n\nTinea pedis and Tinea cruris (NAFT-500):\n\nMale or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH) analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.\n\nTinea pedis (NAFT-600):\n\nMale or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500; both conditions must be characterized by clinical evidence of a Tinea infection.\n* Subjects must have Tinea pedis on both feet for NAFT-600; the condition must be characterized by clinical evidence of a Tinea infection.\n\nExclusion Criteria:\n\n* A known hypersensitivity to study medications or their components\n* Any severe condition of Tinea pedis (incapacitating)\n* Any dermatological disease and or condition in the treatment or surrounding area that may prevent application of the study product such as foot psoriasis, corns and /or callus involving any web spaces, or atopic or contact dermatitis\n* Positive pregnancy test\n* Any history or current evidence (physical or laboratory) of anemia'}, 'identificationModule': {'nctId': 'NCT01712360', 'briefTitle': 'Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of NAFT-500 in Pediatric Subjects With Tinea Cruris and Tinea Pedis and NAFT-600 in Pediatric Subjects With Tinea Pedis', 'orgStudyIdInfo': {'id': 'MUS 90200/1023/0'}, 'secondaryIdInfos': [{'id': 'Tinea Pedis and Cruris'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAFT500 (pediatric)', 'description': 'Topical once a day for two weeks', 'interventionNames': ['Drug: NAFT500 (pediatric)']}, {'type': 'EXPERIMENTAL', 'label': 'NAFT600 (pediatric)', 'description': 'Topical once a day for two weeks', 'interventionNames': ['Drug: NAFT600 (pediatric)']}, {'type': 'EXPERIMENTAL', 'label': 'NAFT500 (adult)', 'description': 'Topical once a day for two weeks', 'interventionNames': ['Drug: NAFT500 (adult)']}, {'type': 'EXPERIMENTAL', 'label': 'NAFT600 (adult)', 'description': 'Topical once a day for two weeks', 'interventionNames': ['Drug: NAFT600 (adult)']}], 'interventions': [{'name': 'NAFT500 (pediatric)', 'type': 'DRUG', 'otherNames': ['NAFT500', 'naftifine', 'naftifine hydrochloride'], 'description': 'Applied to both feet and groin area', 'armGroupLabels': ['NAFT500 (pediatric)']}, {'name': 'NAFT600 (pediatric)', 'type': 'DRUG', 'otherNames': ['NAFT600', 'naftifine', 'naftifine hydrochloride'], 'description': 'Applied to both feet only', 'armGroupLabels': ['NAFT600 (pediatric)']}, {'name': 'NAFT500 (adult)', 'type': 'DRUG', 'otherNames': ['NAFT500', 'naftifine', 'naftifine hydrochloride'], 'description': 'Applied to both feet and groin area', 'armGroupLabels': ['NAFT500 (adult)']}, {'name': 'NAFT600 (adult)', 'type': 'DRUG', 'otherNames': ['NAFT600', 'naftifine', 'naftifine hydrochloride'], 'description': 'Applied to both feet', 'armGroupLabels': ['NAFT600 (adult)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Merz Investigative Site #001272', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77802', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'Merz Investigative Site #001261', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'city': 'Santo Domingo', 'state': 'Santo Domingo Province', 'country': 'Dominican Republic', 'facility': 'Merz Investigative Site #180001'}, {'city': 'San Pedro Sula', 'state': 'San Pedro Sula', 'country': 'Honduras', 'facility': 'Merz Investigative Site #504001', 'geoPoint': {'lat': 15.50585, 'lon': -88.02588}}], 'overallOfficials': [{'name': 'Alan Fleischer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merz Pharmaceutical, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz North America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}