Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-01-05 @ 5:55 PM
Study NCT ID:
NCT01226459
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2010-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial in Females for Female Pattern Hair Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '(973) 385-3203', 'title': 'Study Director', 'organization': 'Johnson & Johnson Healthcare Products Division of MCNEIL-PPC, Inc.'}, 'certainAgreement': {'otherDetails': "Multi-Center Publication will be the first publication to present the results of the Study. Upon such Multi-Center Publication, or the earlier of (a) Sponsor's confirmation that there will be no Multi-Center Publication or presentation, or (b) 12 months after the completion of the entire multi-center study, Institution and Investigator may publish or present Study data and results generated in their performance of the Study in accordance with the terms of this Article.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vehicle Foam', 'description': 'Vehicle Topical Foam\n\nVehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks', 'otherNumAtRisk': 201, 'otherNumAffected': 57, 'seriousNumAtRisk': 201, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Minoxidil Foam', 'description': '5% Minoxidil Topical Foam\n\n5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks', 'otherNumAtRisk': 203, 'otherNumAffected': 63, 'seriousNumAtRisk': 203, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Ovarian Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ovarian Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiovascular Disorder', 'notes': 'Death (1 participant died from cardiovascular disease)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cor Pulmonale Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'notes': 'Death (1 participant died from both renal failure and dehydration). Note that this is the same participant that died from renal failure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Memory Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Post-Traumatic Stress Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal Failure', 'notes': 'Death (1 participant died from both renal failure and dehydration). Note that this is the same participant who died from dehydration.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '2.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Target Area Hair Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Foam', 'description': 'Vehicle Topical Foam\n\nVehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks'}, {'id': 'OG001', 'title': 'Minoxidil Foam', 'description': '5% Minoxidil Topical Foam\n\n5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '152.7', 'spread': '59.7', 'groupId': 'OG000'}, {'value': '158.6', 'spread': '61.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '162.2', 'spread': '63.1', 'groupId': 'OG000'}, {'value': '175.7', 'spread': '65.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '4.0', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '22.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.1', 'ciLowerLimit': '5.0', 'ciUpperLimit': '13.1', 'groupDescription': 'Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in foam group had no hair information at Baseline. Statistical analysis is of the change from baseline to week 24 data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Number of hairs in the area being examined as measured by macrophotography.', 'unitOfMeasure': 'hairs per centimeter squared', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in minoxidil foam group had no hair information at Baseline.'}, {'type': 'SECONDARY', 'title': 'Target Area Hair Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Foam', 'description': 'Vehicle Topical Foam\n\nVehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks'}, {'id': 'OG001', 'title': 'Minoxidil Foam', 'description': '5% Minoxidil Topical Foam\n\n5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '152.7', 'spread': '59.7', 'groupId': 'OG000'}, {'value': '158.6', 'spread': '61.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '163.3', 'spread': '63.2', 'groupId': 'OG000'}, {'value': '178.1', 'spread': '66.4', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '5.4', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '21.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.8', 'ciLowerLimit': '7.0', 'ciUpperLimit': '14.7', 'groupDescription': 'Statistical analysis is of the change from baseline to week 12 data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of hairs in the area being examined as measured by macrophotography.', 'unitOfMeasure': 'hairs per centimeter squared', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in the vehicle foam group and 3 participants in the minoxidil foam group had no hair count information at Baseline.'}, {'type': 'PRIMARY', 'title': 'Subject Assessment of Scalp Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle Foam', 'description': 'Vehicle Topical Foam\n\nVehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks'}, {'id': 'OG001', 'title': 'Minoxidil Foam', 'description': '5% Minoxidil Topical Foam\n\n5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '1.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Eighteen participants in vehicle foam group and 23 participants in minoxidil foam group had no scalp coverage information.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vehicle Foam', 'description': 'Vehicle Topical Foam\n\nVehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks'}, {'id': 'FG001', 'title': 'Minoxidil Foam', 'description': '5% Minoxidil Topical Foam\n\n5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vehicle Foam', 'description': 'Vehicle Topical Foam\n\nVehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks'}, {'id': 'BG001', 'title': 'Minoxidil Foam', 'description': '5% Minoxidil Topical Foam\n\n5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'One participant in minoxidil foam group had no information on race and hair loss duration', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 404}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'dispFirstSubmitDate': '2012-08-30', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2010-10-20', 'dispFirstSubmitQcDate': '2012-08-30', 'resultsFirstSubmitDate': '2014-03-26', 'studyFirstSubmitQcDate': '2010-10-21', 'dispFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-08', 'studyFirstPostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Area Hair Count', 'timeFrame': 'Baseline to Week 24', 'description': 'Number of hairs in the area being examined as measured by macrophotography.'}, {'measure': 'Subject Assessment of Scalp Coverage', 'timeFrame': 'Week 24', 'description': 'Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.'}], 'secondaryOutcomes': [{'measure': 'Target Area Hair Count', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of hairs in the area being examined as measured by macrophotography.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Female Pattern Baldness'], 'conditions': ['Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.', 'detailedDescription': 'This is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center, 24-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the 5% MTF formulation versus the foam vehicle formulation.\n\nThis clinical trial is designed to compare the risk/benefit profile of the new 5% MTF formulation applied once a day (OD) versus the foam vehicle formulation applied once a day (OD), using objective efficacy measures and safety assessments.\n\nStudy centers will screen a sufficient number of participants so that a minimum of 300 female participants with FPHL will be enrolled, to ensure 260 complete. There will be at least 16 participants enrolled per center at multiple centers located across the US and globally. Approximately 300 participants will be randomly assigned in a 1:1 ratio to use either 5% MTF OD or foam vehicle OD, for 24 weeks for efficacy and safety evaluations.\n\nParticipants meeting the inclusion criteria will be randomly assigned in the order of their enrollment at each site. The signing of the informed consent and assignment of a participant number to a subject shall constitute enrollment.\n\nDuring the trial following enrollment at Baseline, participants will return to the study site at Weeks 1, 6, 12, 18 and 24 for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12 and 24 visits, efficacy assessments will also be conducted, using Target Area Hair Counts (TAHC), measured by macrophotography.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* females, age 18 or older in general good health\n* exhibits female pattern hair loss\n* signs and dates an informed consent document\n* agrees to use an adequate method of birth control; if of childbearing potential\n* shows a negative urine pregnancy test at Screening Visit\n* is willing to maintain the same hair style, hair color, and hair regimen throughout the study\n* is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures\n\nExclusion Criteria:\n\n* hypersensitivity to the (study product), or any ingredients of the (study product)\n* known allergy to hair dye, or hair dye components\n* clinically relevant history of hypotension\n* untreated or uncontrolled hypertension\n* pregnant, planning a pregnancy or nursing a child\n* history of hair transplants\n* currently use hair weaves or non-breathable wigs\n* dermatologic disorders of the scalp that require chronic use of medication for control\n* other types or history of hair loss\n* enrolled in any other investigational medication (drug) study currently, or within the last 6 months'}, 'identificationModule': {'nctId': 'NCT01226459', 'briefTitle': 'Clinical Trial in Females for Female Pattern Hair Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Consumer and Personal Products Worldwide'}, 'officialTitle': 'A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam vs. Vehicle in Females for the Treatment of Female Pattern Hair Loss (Androgenetic Alopecia)', 'orgStudyIdInfo': {'id': 'MINALO3005'}, 'secondaryIdInfos': [{'id': '2010-019881-96', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minoxidil Foam', 'description': '5% Minoxidil Topical Foam', 'interventionNames': ['Drug: 5% Minoxidil Topical Foam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Foam', 'description': 'Vehicle Topical Foam', 'interventionNames': ['Drug: Vehicle Topical Foam']}], 'interventions': [{'name': '5% Minoxidil Topical Foam', 'type': 'DRUG', 'otherNames': ['Not yet marketed'], 'description': 'Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks', 'armGroupLabels': ['Minoxidil Foam']}, {'name': 'Vehicle Topical Foam', 'type': 'DRUG', 'otherNames': ['Vehicle Control (Placebo)'], 'description': 'Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks', 'armGroupLabels': ['Vehicle Foam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Axis Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Axis Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates LLC', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '20769', 'city': 'Glenn Dale', 'state': 'Maryland', 'country': 'United States', 'facility': 'Callender Skin & Laser Center', 'geoPoint': {'lat': 38.98761, 'lon': -76.82053}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Center for Skin Care Research', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Derm Research Center of New York', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'J&S Studies, Inc.', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'David A. Whiting, MD PA', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Education & Research Foundation Inc', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Hôpital Saint Jacques Service de Dermatologie', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Clinical Research Center for Hair and Skin Science Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '79098', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Dermaticum Practice for Dermatology', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': 'CV10 7DJ', 'city': 'Nuneaton', 'country': 'United Kingdom', 'facility': 'George Eliot Hospital', 'geoPoint': {'lat': 52.52323, 'lon': -1.46523}}], 'overallOfficials': [{'name': 'Clare Kendall', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Consumer and Personal Products Worldwide'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Johnson & Johnson Consumer and Personal Products Worldwide', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}