Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-07 @ 5:04 PM
Study NCT ID:
NCT02343627
Status:
COMPLETED
Last Update Posted:
2018-09-19
First Post:
2014-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'Natalie.Yantovskiy@Taro.com', 'phone': '+1 914-345-900', 'title': 'Senior Director, Clinical', 'organization': 'Taro Pharmaceuticals U.S.A. Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'NVXT Solution', 'description': 'NVXT Solution once daily for 60 days\n\nNVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.', 'otherNumAtRisk': 35, 'otherNumAffected': 7, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle of Test Product', 'description': 'Vehicle of test product, once daily for 60 days\n\nVehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Common Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of Tinea Pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Negative Fungal Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVXT Solution', 'description': 'NVXT Solution once daily for 60 days\n\nNVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.'}, {'id': 'OG001', 'title': 'Vehicle of Test Product', 'description': 'Vehicle of test product, once daily for 60 days\n\nVehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with fungal culture collected at the study day 28 visit. The subjects may not complete all study visits.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NVXT Solution', 'description': 'NVXT Solution once daily for 60 days\n\nNVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.'}, {'id': 'FG001', 'title': 'Vehicle of Test Product', 'description': 'Vehicle of test product, once daily for 60 days\n\nVehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NVXT Solution', 'description': 'NVXT Solution once daily for 60 days\n\nNVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.'}, {'id': 'BG001', 'title': 'Vehicle of Test Product', 'description': 'Vehicle of test product, once daily for 60 days\n\nVehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.'}, {'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': '35', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2014-12-27', 'resultsFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2015-01-21', 'lastUpdatePostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-21', 'studyFirstPostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Negative Fungal Culture', 'timeFrame': '28 days', 'description': 'To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.', 'detailedDescription': 'This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically diagnosed onychomycosis\n* Presence of dermatophyte fungal infection with no current topical or systemic antifungal therapy\n* Clinical diagnosis of mild-to-moderate fungal infection of at least one toe involving 10-50% of the nail area, without involvement of one of the lunular proximal regions\n* Positive potassium hydroxide mount preparation\n* Positive fungal culture for a dermatophyte\n\nExclusion Criteria:\n\n* Nail or anatomical abnormalities of the toe that may interfere with evaluations or dosing compliance'}, 'identificationModule': {'nctId': 'NCT02343627', 'briefTitle': 'Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Safety and Efficacy of NVXT Solution in Patients With Mild-to-Moderate Fungal Infection of the Toe Nail', 'orgStudyIdInfo': {'id': 'NVXT 1405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NVXT Solution', 'description': 'NVXT Solution once daily for 60 days', 'interventionNames': ['Drug: NVXT Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle of test product', 'description': 'Vehicle of test product, once daily for 60 days', 'interventionNames': ['Drug: Vehicle of test product']}], 'interventions': [{'name': 'NVXT Solution', 'type': 'DRUG', 'otherNames': ['NVXT'], 'description': 'NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.', 'armGroupLabels': ['NVXT Solution']}, {'name': 'Vehicle of test product', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.', 'armGroupLabels': ['Vehicle of test product']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Taro Pharmaceuticals USA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taro Pharmaceuticals USA Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}