Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 5:16 PM
Study NCT ID:
NCT01278394
Status:
COMPLETED
Last Update Posted:
2018-12-06
First Post:
2011-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014009', 'term': 'Onychomycosis'}], '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': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@anacor.com', 'phone': '650-223-8597', 'title': 'Sheryl Baldwin, RN/Associate Director', 'organization': 'Anacor Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'Institution or Principal Investigator may only publish Study results after: (i) the results of the multicenter Study in its entirety have been publicly disclosed by the Sponsor in an abstract, manuscript or presentation form, or (ii) two (2) years after conclusion of the Study at all sites, whichever is first to occur.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Pre and post treatment to Day 360', 'description': "AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.", 'eventGroups': [{'id': 'EG000', 'title': 'AN2690 Solution, 5.0%', 'description': 'AN2690 Solution, 5.0%: Once daily application for 360 days', 'otherNumAtRisk': 29, 'otherNumAffected': 16, 'seriousNumAtRisk': 29, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Blood glucose abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Polycystic ovaries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Ingrowing nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Onychomadesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}], 'seriousEvents': [{'term': 'Uterine haemorrhage (unrelated)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 9.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2690 Solution, 5.0%', 'description': 'AN2690 Solution, 5.0%: Once daily application for 360 days'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '16.1'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 360', 'description': 'Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed for the ITT population. For efficacy variables, the last observation was carried forward (LOCF) to impute missing observations.'}, {'type': 'SECONDARY', 'title': 'Clear Nail Growth of the Targeted Toenail', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2690 Solution, 5.0%', 'description': 'AN2690 Solution, 5.0%: Once daily application for 360 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 360', 'description': 'Clear nail was measured on digital images as the distance in millimeters from the proximal nail fold to the proximal limit of the disease as marked by the Investigator. New Clear Nail Growth (CNG) was calculated from the clear nail measurements.', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.'}, {'type': 'SECONDARY', 'title': 'Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2690 Solution, 5.0%', 'description': 'AN2690 Solution, 5.0%: Once daily application for 360 days'}], 'classes': [{'title': 'Fungal Culture Result Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fungal Culture Result Negative', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': '100'}]}]}, {'title': 'KOH Result Positive', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'KOH Result Negative', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '31.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': 'Number of subjects with negative KOH, and number of subjects with negative fungal cultures.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.'}, {'type': 'SECONDARY', 'title': 'Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2690 Solution, 5.0%', 'description': 'AN2690 Solution, 5.0%: Once daily application for 360 days'}], 'classes': [{'title': 'Fungal Culture Result Positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fungal Culture Result Negative', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'KOH Result Positive', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'KOH Result Negative', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '47.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 180', 'description': 'Number of subjects with negative KOH, and number of subjects with negative fungal cultures.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.'}, {'type': 'SECONDARY', 'title': 'Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2690 Solution, 5.0%', 'description': 'AN2690 Solution, 5.0%: Once daily application for 360 days'}], 'classes': [{'title': 'Fungal Culture Result Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fungal Culture Result Negative', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': '100'}]}]}, {'title': 'KOH Result Positive', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'KOH Result Negative', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '23.5', 'upperLimit': '59.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 270', 'description': 'Number of subjects with negative KOH, and number of subjects with negative fungal cultures.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.'}, {'type': 'SECONDARY', 'title': 'Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2690 Solution, 5.0%', 'description': 'AN2690 Solution, 5.0%: Once daily application for 360 days'}], 'classes': [{'title': 'Fungal Culture Result Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fungal Culture Result Negative', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': '100'}]}]}, {'title': 'KOH Result Positive', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'KOH Result Negative', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '35.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 360', 'description': 'Number of subjects with negative KOH, and number of subjects with negative fungal cultures.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.'}, {'type': 'SECONDARY', 'title': 'Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2690 Solution, 5.0%', 'description': 'AN2690 Solution, 5.0%: Once daily application for 360 days'}], 'classes': [{'categories': [{'measurements': [{'value': '138.0', 'groupId': 'OG000', 'lowerLimit': '81.5', 'upperLimit': '194'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 360', 'description': 'Length of time to clinical evaluation of clear or at least 5 mm of CNG.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AN2690 Solution, 5.0%', 'description': 'AN2690 Solution, 5.0%: Once daily application for 360 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were screened and enrolled and two investigative sites in Mexico. The study population included men and women of any race, 18-65 years of age who had distal, subungual onychomycosis of the great toenail. The first subject visit occurred on March 28, 2007, and the last subject visit occurred on July 11, 2008.', 'preAssignmentDetails': 'All subjects in Cohort 3 were treated with 5.0% AN2690 Solution.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AN2690 Solution, 5.0%', 'description': 'AN2690 Solution, 5.0%: Once daily application for 360 days'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age', 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'spread': '10.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All analyses were performed using the intent-to-treat (ITT) population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'dispFirstSubmitDate': '2014-01-18', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-13', 'studyFirstSubmitDate': '2011-01-14', 'dispFirstSubmitQcDate': '2014-02-12', 'resultsFirstSubmitDate': '2014-07-25', 'studyFirstSubmitQcDate': '2011-01-14', 'dispFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-25', 'studyFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360', 'timeFrame': 'Day 360', 'description': 'Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.'}], 'secondaryOutcomes': [{'measure': 'Clear Nail Growth of the Targeted Toenail', 'timeFrame': 'Day 360', 'description': 'Clear nail was measured on digital images as the distance in millimeters from the proximal nail fold to the proximal limit of the disease as marked by the Investigator. New Clear Nail Growth (CNG) was calculated from the clear nail measurements.'}, {'measure': 'Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline', 'timeFrame': 'Day 90', 'description': 'Number of subjects with negative KOH, and number of subjects with negative fungal cultures.'}, {'measure': 'Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline', 'timeFrame': 'Day 180', 'description': 'Number of subjects with negative KOH, and number of subjects with negative fungal cultures.'}, {'measure': 'Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline', 'timeFrame': 'Day 270', 'description': 'Number of subjects with negative KOH, and number of subjects with negative fungal cultures.'}, {'measure': 'Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline', 'timeFrame': 'Day 360', 'description': 'Number of subjects with negative KOH, and number of subjects with negative fungal cultures.'}, {'measure': 'Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG', 'timeFrame': 'Baseline to 360', 'description': 'Length of time to clinical evaluation of clear or at least 5 mm of CNG.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Onychomycosis', 'Fungal Nail'], 'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.', 'detailedDescription': 'In this cohort, only the targeted great toenail identified at Baseline prior to the commencement of treatment from culture results collected at the Screening visit were evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At each visit, the investigator was asked to make a clinical evaluation of the targeted great nail, marking whether or not they considered the nail to be clear of onychomycosis. This evaluation was the basis for determining whether or not study medication should be dispensed at the visit.\n\nThis record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and 2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1\\&2 and Cohort 3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects must meet all of the following criteria to be included in the study:\n2. Witnessed, signed informed consent approved by Ethics Committee.\n3. Male or female subjects of any race at least 18 years of age but not older than 65 years of age at the time of screening.\n4. For Cohorts 1 and 2, subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail. For Cohort 3, subjects must have a diagnosis of onychomycosis of at least one great toenail and a positive KOH wet mount AND fungal culture from that nail.\n5. Onychomycosis involving 20-60% of the affected great toenail as determined by visual inspection after the nail has been trimmed.\n6. The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed \\<3 mm.\n7. Affected great toenail to be treated is capable of re-growth as documented by history or recent observation of at least 2 mm of growth.\n8. Normal or not clinically significant screening safety labs.\n\nExclusion Criteria:\n\n1. Females of childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study.\n2. Diabetes mellitus requiring treatment other than diet and exercise.\n3. Subjects with chronic moccasin type of T. pedis.\n4. Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis.\n5. Subjects unwilling to refrain from the use of nail cosmetics such as clear and or colored nail lacquers from the screening visit until the end of the study.\n6. Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications:\n\n * Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks\n * Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks\n7. Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:\n\n * Corticosteroids (including intramuscular injections): 2 weeks\n * Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophytes: 24 weeks\n * Systemic immunomodulators: 4 weeks\n8. Treatment of any type for cancer within the last 6 months.\n9. History of any significant internal disease.\n10. Subjects with a medical history of current or past psoriasis of the skin and/or nails.\n11. Concurrent lichen planus.\n12. Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.\n13. Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated.\n14. AIDS or AIDS related complex.\n15. History of street drug or alcohol abuse.\n16. Any subject not able to meet the study attendance requirements.\n17. Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study."}, 'identificationModule': {'nctId': 'NCT01278394', 'briefTitle': 'Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open-Label, Rising Multiple-Dose, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 5.0% and 7.5% Solution for the Treatment of Adult Subjects With Onychomycosis of the Great Toenail', 'orgStudyIdInfo': {'id': 'AN2690-ONYC-201'}, 'secondaryIdInfos': [{'id': 'AN2690-ONYC-201 Cohort 3', 'type': 'OTHER', 'domain': 'Anacor'}, {'id': 'C3371009', 'type': 'OTHER', 'domain': 'Pfizer'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'AN2690 Solution, 5.0%', 'interventionNames': ['Drug: AN2690 Solution, 5.0%']}], 'interventions': [{'name': 'AN2690 Solution, 5.0%', 'type': 'DRUG', 'description': 'Once daily application for 360 days', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Instituto Dermatologico Jalisciense', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'IMIC', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}