Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-28 @ 1:19 PM
Study NCT ID:
NCT01325350
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2011-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Bimatoprost in the Treatment of Women With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008914', 'term': 'Minoxidil'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'Bimatoprost Formulation A', 'description': 'Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'otherNumAtRisk': 61, 'otherNumAffected': 17, 'seriousNumAtRisk': 61, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Bimatoprost Formulation B', 'description': 'Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'otherNumAtRisk': 60, 'otherNumAffected': 17, 'seriousNumAtRisk': 60, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Bimatoprost Formulation C', 'description': 'Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'otherNumAtRisk': 60, 'otherNumAffected': 15, 'seriousNumAtRisk': 60, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Vehicle to Bimatoprost', 'description': 'Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'otherNumAtRisk': 61, 'otherNumAffected': 20, 'seriousNumAtRisk': 61, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Minoxidil 2% Solution', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.', 'otherNumAtRisk': 61, 'otherNumAffected': 24, 'seriousNumAtRisk': 61, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Application site pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Application site dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypertrichosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'seriousEvents': [{'term': 'Death', 'notes': 'Event not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cholecystitis', 'notes': 'Event not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Appendicitis', 'notes': 'Event not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastroenteritis', 'notes': 'Event not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Osteoarthritis', 'notes': 'Events not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Arthralgia', 'notes': 'Event not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Rotator cuff syndrome', 'notes': 'Event not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Intervertebral disc protrusion', 'notes': 'Events not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Chondropathy', 'notes': 'Event not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Benign ovarian tumour', 'notes': 'Event not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Syncope', 'notes': 'Event not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumothorax', 'notes': 'Event not treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Target Area Hair Count (TAHC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost Formulation A', 'description': 'Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG001', 'title': 'Bimatoprost Formulation B', 'description': 'Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG002', 'title': 'Bimatoprost Formulation C', 'description': 'Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG003', 'title': 'Vehicle to Bimatoprost', 'description': 'Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG004', 'title': 'Minoxidil 2% Solution', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '153.1', 'spread': '54.78', 'groupId': 'OG000'}, {'value': '161.1', 'spread': '63.85', 'groupId': 'OG001'}, {'value': '145.2', 'spread': '63.42', 'groupId': 'OG002'}, {'value': '163.0', 'spread': '57.28', 'groupId': 'OG003'}, {'value': '156.3', 'spread': '55.46', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '17.10', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '18.21', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '16.82', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '20.44', 'groupId': 'OG003'}, {'value': '13.6', 'spread': '18.72', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs). A negative change from Baseline indicated worsening (decrease in the number of terminal hairs).', 'unitOfMeasure': 'terminal hairs/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost Formulation A', 'description': 'Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG001', 'title': 'Bimatoprost Formulation B', 'description': 'Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG002', 'title': 'Bimatoprost Formulation C', 'description': 'Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG003', 'title': 'Vehicle to Bimatoprost', 'description': 'Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG004', 'title': 'Minoxidil 2% Solution', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.'}], 'classes': [{'title': 'Greatly Increased', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '9.3', 'groupId': 'OG002'}, {'value': '3.3', 'groupId': 'OG003'}, {'value': '7.1', 'groupId': 'OG004'}]}]}, {'title': 'Moderately Increased', 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '18.0', 'groupId': 'OG003'}, {'value': '28.6', 'groupId': 'OG004'}]}]}, {'title': 'Slightly Increased', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '24.6', 'groupId': 'OG003'}, {'value': '35.7', 'groupId': 'OG004'}]}]}, {'title': 'Remained the Same', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '38.9', 'groupId': 'OG002'}, {'value': '29.5', 'groupId': 'OG003'}, {'value': '19.6', 'groupId': 'OG004'}]}]}, {'title': 'Slightly Decreased', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}, {'value': '13.0', 'groupId': 'OG002'}, {'value': '13.1', 'groupId': 'OG003'}, {'value': '5.4', 'groupId': 'OG004'}]}]}, {'title': 'Moderately Decreased', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}, {'value': '8.2', 'groupId': 'OG003'}, {'value': '1.8', 'groupId': 'OG004'}]}]}, {'title': 'Greatly Decreased', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '3.3', 'groupId': 'OG003'}, {'value': '1.8', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 6', 'description': 'The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost Formulation A', 'description': 'Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG001', 'title': 'Bimatoprost Formulation B', 'description': 'Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG002', 'title': 'Bimatoprost Formulation C', 'description': 'Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG003', 'title': 'Vehicle to Bimatoprost', 'description': 'Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG004', 'title': 'Minoxidil 2% Solution', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.'}], 'classes': [{'title': 'Greatly Increased', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '7.4', 'groupId': 'OG002'}, {'value': '1.6', 'groupId': 'OG003'}, {'value': '1.8', 'groupId': 'OG004'}]}]}, {'title': 'Moderately Increased', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '11.1', 'groupId': 'OG002'}, {'value': '14.8', 'groupId': 'OG003'}, {'value': '16.1', 'groupId': 'OG004'}]}]}, {'title': 'Slightly Increased', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '35.0', 'groupId': 'OG001'}, {'value': '25.9', 'groupId': 'OG002'}, {'value': '23.0', 'groupId': 'OG003'}, {'value': '37.5', 'groupId': 'OG004'}]}]}, {'title': 'Remained the Same', 'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '51.9', 'groupId': 'OG002'}, {'value': '54.1', 'groupId': 'OG003'}, {'value': '41.1', 'groupId': 'OG004'}]}]}, {'title': 'Slightly Decreased', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}, {'value': '6.6', 'groupId': 'OG003'}, {'value': '3.6', 'groupId': 'OG004'}]}]}, {'title': 'Moderately Decreased', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'Greatly Decreased', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 6', 'description': 'The investigator compared the participant\'s scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject\'s hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost Formulation A', 'description': 'Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG001', 'title': 'Bimatoprost Formulation B', 'description': 'Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG002', 'title': 'Bimatoprost Formulation C', 'description': 'Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG003', 'title': 'Vehicle to Bimatoprost', 'description': 'Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG004', 'title': 'Minoxidil 2% Solution', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.'}], 'classes': [{'title': 'Greatly Increased', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'Moderately Increased', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}, {'value': '1.6', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'Slightly Increased', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}, {'value': '6.3', 'groupId': 'OG002'}, {'value': '6.6', 'groupId': 'OG003'}, {'value': '17.0', 'groupId': 'OG004'}]}]}, {'title': 'Remained the Same', 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000'}, {'value': '81.4', 'groupId': 'OG001'}, {'value': '81.3', 'groupId': 'OG002'}, {'value': '88.5', 'groupId': 'OG003'}, {'value': '79.2', 'groupId': 'OG004'}]}]}, {'title': 'Slightly Decreased', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}, {'value': '10.4', 'groupId': 'OG002'}, {'value': '3.3', 'groupId': 'OG003'}, {'value': '1.9', 'groupId': 'OG004'}]}]}, {'title': 'Moderately Decreased', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '1.9', 'groupId': 'OG004'}]}]}, {'title': 'Greatly Decreased', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 6', 'description': 'At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant\'s scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject\'s hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Target Area Hair Width (TAHW)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost Formulation A', 'description': 'Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG001', 'title': 'Bimatoprost Formulation B', 'description': 'Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG002', 'title': 'Bimatoprost Formulation C', 'description': 'Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG003', 'title': 'Vehicle to Bimatoprost', 'description': 'Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG004', 'title': 'Minoxidil 2% Solution', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.92', 'spread': '3.444', 'groupId': 'OG000'}, {'value': '9.64', 'spread': '3.308', 'groupId': 'OG001'}, {'value': '8.86', 'spread': '3.977', 'groupId': 'OG002'}, {'value': '10.13', 'spread': '4.165', 'groupId': 'OG003'}, {'value': '9.76', 'spread': '3.698', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline from Month 6', 'categories': [{'measurements': [{'value': '0.13', 'spread': '1.198', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '1.067', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '1.263', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '1.183', 'groupId': 'OG003'}, {'value': '0.87', 'spread': '1.315', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm\\^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). A negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).', 'unitOfMeasure': 'mm/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Target Area Hair Darkness (TAHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost Formulation A', 'description': 'Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG001', 'title': 'Bimatoprost Formulation B', 'description': 'Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG002', 'title': 'Bimatoprost Formulation C', 'description': 'Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG003', 'title': 'Vehicle to Bimatoprost', 'description': 'Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'OG004', 'title': 'Minoxidil 2% Solution', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '95.63', 'spread': '23.837', 'groupId': 'OG000'}, {'value': '100.12', 'spread': '25.077', 'groupId': 'OG001'}, {'value': '92.76', 'spread': '19.433', 'groupId': 'OG002'}, {'value': '96.90', 'spread': '22.678', 'groupId': 'OG003'}, {'value': '93.07', 'spread': '20.667', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '2.94', 'spread': '13.084', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '13.159', 'groupId': 'OG001'}, {'value': '2.11', 'spread': '14.674', 'groupId': 'OG002'}, {'value': '2.07', 'spread': '11.486', 'groupId': 'OG003'}, {'value': '2.12', 'spread': '11.561', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).', 'unitOfMeasure': 'Intensity units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bimatoprost Formulation A', 'description': 'Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'FG001', 'title': 'Bimatoprost Formulation B', 'description': 'Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'FG002', 'title': 'Bimatoprost Formulation C', 'description': 'Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'FG003', 'title': 'Vehicle to Bimatoprost', 'description': 'Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'FG004', 'title': 'Minoxidil 2% Solution', 'description': 'Approximately one mL of minoxidil 2% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '61'}, {'groupId': 'FG004', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Did Not Receive Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '306', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Bimatoprost Formulation A', 'description': 'Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'BG001', 'title': 'Bimatoprost Formulation B', 'description': 'Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'BG002', 'title': 'Bimatoprost Formulation C', 'description': 'Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'BG003', 'title': 'Vehicle to Bimatoprost', 'description': 'Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.'}, {'id': 'BG004', 'title': 'Minoxidil 2% Solution', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 34 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}]}]}, {'title': '35 to 59 years', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '244', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '306', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'dispFirstSubmitDate': '2013-07-31', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-03', 'studyFirstSubmitDate': '2011-03-28', 'dispFirstSubmitQcDate': '2013-07-31', 'resultsFirstSubmitDate': '2014-03-03', 'studyFirstSubmitQcDate': '2011-03-28', 'dispFirstPostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-03', 'studyFirstPostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Target Area Hair Count (TAHC)', 'timeFrame': 'Baseline, Month 6', 'description': 'TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs). A negative change from Baseline indicated worsening (decrease in the number of terminal hairs).'}, {'measure': 'Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score', 'timeFrame': 'Baseline, Month 6', 'description': 'The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score', 'timeFrame': 'Baseline, Month 6', 'description': 'The investigator compared the participant\'s scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject\'s hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.'}, {'measure': 'Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score', 'timeFrame': 'Baseline, Month 6', 'description': 'At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant\'s scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject\'s hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.'}, {'measure': 'Change From Baseline in Target Area Hair Width (TAHW)', 'timeFrame': 'Baseline, Month 6', 'description': 'Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm\\^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). A negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).'}, {'measure': 'Change From Baseline in Target Area Hair Darkness (TAHD)', 'timeFrame': 'Baseline, Month 6', 'description': 'Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alopecia', 'Baldness']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild to moderate female pattern hair loss with ongoing hair loss for at least 1 year\n* Willingness to have micro-dot-tattoo applied to scalp\n* Willingness to maintain same hair style, length and hair color during study\n\nExclusion Criteria:\n\n* Drug or alcohol abuse within 12 months\n* HIV positive\n* Received hair transplants or had scalp reductions\n* Use of hair weaves, hair extensions or wigs within 3 months\n* Oral or topical minoxidil treatment within 6 months\n* Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks'}, 'identificationModule': {'nctId': 'NCT01325350', 'briefTitle': 'Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '192024-058'}, 'secondaryIdInfos': [{'id': '2011-000380-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bimatoprost Formulation A', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'interventionNames': ['Drug: bimatoprost Formulation A']}, {'type': 'EXPERIMENTAL', 'label': 'bimatoprost Formulation B', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'interventionNames': ['Drug: bimatoprost Formulation B']}, {'type': 'EXPERIMENTAL', 'label': 'bimatoprost Formulation C', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'interventionNames': ['Drug: bimatoprost Formulation C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'bimatoprost vehicle solution', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'interventionNames': ['Drug: bimatoprost vehicle solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'minoxidil 2% solution', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.', 'interventionNames': ['Drug: minoxidil 2% solution']}], 'interventions': [{'name': 'bimatoprost Formulation A', 'type': 'DRUG', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'armGroupLabels': ['bimatoprost Formulation A']}, {'name': 'bimatoprost Formulation B', 'type': 'DRUG', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'armGroupLabels': ['bimatoprost Formulation B']}, {'name': 'bimatoprost Formulation C', 'type': 'DRUG', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'armGroupLabels': ['bimatoprost Formulation C']}, {'name': 'bimatoprost vehicle solution', 'type': 'DRUG', 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.', 'armGroupLabels': ['bimatoprost vehicle solution']}, {'name': 'minoxidil 2% solution', 'type': 'DRUG', 'otherNames': ['Rogaine®', 'Regaine®'], 'description': 'Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.', 'armGroupLabels': ['minoxidil 2% solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}