Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-28 @ 1:26 PM
Study NCT ID:
NCT01208168
Status:
TERMINATED
Last Update Posted:
2013-07-11
First Post:
2010-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 468}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'dispFirstSubmitDate': '2013-07-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-08', 'studyFirstSubmitDate': '2010-09-20', 'dispFirstSubmitQcDate': '2013-07-08', 'studyFirstSubmitQcDate': '2010-09-22', 'dispFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.', 'timeFrame': 'Week 56 after 52 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (Clear or almost clear).', 'timeFrame': 'Week 56'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['toenail fungus', 'onychomycosis', 'nail infection'], 'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate fungal infection of the toenail as assessed by study doctor\n* koh positive \\& dermatophyte culture positive at Visit 1\n* good general health as assessed by the study doctor\n\nExclusion Criteria:\n\n* severe fungal toenail infection\n* prior use of antifungal drugs (wash-out allowed, duration varies on class)\n* significant confounding conditions as assessed by study doctor\n* pregnancy/lactation\n* must forego nail salon procedures during study for at least \\~60 weeks'}, 'identificationModule': {'nctId': 'NCT01208168', 'briefTitle': 'Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails', 'organization': {'class': 'INDUSTRY', 'fullName': 'Promius Pharma, LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Wks', 'orgStudyIdInfo': {'id': '0904'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active drug', 'interventionNames': ['Drug: NAB001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle alone', 'interventionNames': ['Drug: Vehicle alone']}], 'interventions': [{'name': 'NAB001', 'type': 'DRUG', 'description': 'nail lacquer, once daily, 52 weeks', 'armGroupLabels': ['Active drug']}, {'name': 'Vehicle alone', 'type': 'DRUG', 'description': 'nail lacquer, once daily, 52 weeks', 'armGroupLabels': ['Vehicle alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arkansas', 'country': 'United States'}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'T. Joseph Raoof, MD, Inc.', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92117', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Skin Surgery Medical Group, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80501', 'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'facility': 'Longmont Medical Research Network', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Internaional Dermatology Research, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30263', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'MedaPhase, Inc.', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Atlanta', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Northwest Clinical Trials', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '11733', 'city': 'East Setauket', 'state': 'New York', 'country': 'United States', 'facility': 'Gerard Furst, DPM, PLLC', 'geoPoint': {'lat': 40.94149, 'lon': -73.10594}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology Consulting Services', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mazur Foot and Ankle', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '45249', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Dermatology & Research Network', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University - School of Podiatric Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29681', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Dermatology of Greenville, PA', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Research Center', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75243', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Ashton Podiatry Associates, PA', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Progressive Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Instituto Dermatologica', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Instituto Dermatologico', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}], 'overallOfficials': [{'name': 'Kent Allenby, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Promius Pharma'}, {'name': 'Joanne Fraser, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Promius Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Promius Pharma, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}