Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT01431820
Status:
COMPLETED
Last Update Posted:
2015-11-30
First Post:
2011-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'dispFirstSubmitDate': '2015-11-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-02', 'studyFirstSubmitDate': '2011-09-08', 'dispFirstSubmitQcDate': '2015-11-02', 'studyFirstSubmitQcDate': '2011-09-09', 'dispFirstPostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects who achieve complete cure of the target great toenail', 'timeFrame': 'Week 52'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Onychomycosis', 'Toenail Fungus', 'luliconazole', 'Antifungal', 'Topical'], 'conditions': ['Distal and Lateral Subungual Onychomycosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/23545529', 'label': 'Safety and Tolerability of Luliconazole Solution, 10% in Patients with Moderate to Severe Distal Subungual Onychomycosis. Jones T, Tavakkol A. Antimicrob Agents Chemother. 2013 Apr 1. \\[Epub ahead of print\\]'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of a topical antifungal formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the toenails.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects of either gender, any race and between the ages of 18 and 70 inclusive\n* Subjects with a clinical diagnosis with culture confirmation of distal subungual onychomycosis (DSO) - Subjects must be free of any disease that in the Investigator's opinion might interfere with the study evaluations or jeopardize the subject's safety\n\nExclusion Criteria:\n\n* Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution\n* Subjects who are currently participating or have recently participated in another investigational medication or device study"}, 'identificationModule': {'nctId': 'NCT01431820', 'acronym': 'SOLUTION', 'briefTitle': 'Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis', 'nctIdAliases': ['NCT01428856'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Topica Pharmaceuticals'}, 'officialTitle': 'Safety and Efficacy of Luliconazole Solution, 10% With Two Dosing Regimens in Distal Subungual Onychomycosis of the Toenails: A Randomized, Double-Blind, Vehicle-Controlled, Phase 2B/3 Study', 'orgStudyIdInfo': {'id': 'TP-1009-S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Luliconazole Solution, 10% Regimen 1', 'interventionNames': ['Drug: Luliconazole Solution, 10%']}, {'type': 'EXPERIMENTAL', 'label': 'Luliconazole Solution, 10% Regimen 2', 'interventionNames': ['Drug: Luliconazole Solution, 10%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Solution Regimen 1', 'interventionNames': ['Drug: Vehicle Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Solution Regimen 2', 'interventionNames': ['Drug: Vehicle Solution']}], 'interventions': [{'name': 'Luliconazole Solution, 10%', 'type': 'DRUG', 'description': 'Topical', 'armGroupLabels': ['Luliconazole Solution, 10% Regimen 1', 'Luliconazole Solution, 10% Regimen 2']}, {'name': 'Vehicle Solution', 'type': 'DRUG', 'description': 'Topical', 'armGroupLabels': ['Vehicle Solution Regimen 1', 'Vehicle Solution Regimen 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92119', 'city': 'San Diego', 'state': 'California', 'country': 'United 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'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37922', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77840', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '75243', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United 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