Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-01 @ 2:00 AM
Study NCT ID:
NCT01008033
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2009-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 870}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-20', 'studyFirstSubmitDate': '2009-11-03', 'studyFirstSubmitQcDate': '2009-11-03', 'lastUpdatePostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients who achieve clinical cure', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients who achieve clinical efficacy', 'timeFrame': '52 weeks'}, {'measure': 'Percentage of patients who achieve mycologic cure', 'timeFrame': '52 weeks'}]}, 'conditionsModule': {'conditions': ['Onychomycosis']}, 'referencesModule': {'references': [{'pmid': '25007364', 'type': 'DERIVED', 'citation': 'Gupta AK, Elewski BE, Sugarman JL, Ieda C, Kawabata H, Kang R, Pillai R, Olin JT, Watanabe S. The efficacy and safety of efinaconazole 10% solution for treatment of mild to moderate onychomycosis: a pooled analysis of two phase 3 randomized trials. J Drugs Dermatol. 2014 Jul;13(7):815-20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically diagnosed onychomycosis of the target nail\n* Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected\n* Has a positive KOH examination from the target nail\n* Has a positive dermatophyte culture from the target nail\n\nExclusion Criteria:\n\n* Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug\n* Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis\n* Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit\n* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period'}, 'identificationModule': {'nctId': 'NCT01008033', 'briefTitle': 'Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dow Pharmaceutical Sciences'}, 'orgStudyIdInfo': {'id': 'DPSI-IDP-108-P3-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDP-108', 'interventionNames': ['Drug: IDP-108']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'IDP-108', 'type': 'DRUG', 'description': 'Topical application once a day for 48 weeks', 'armGroupLabels': ['IDP-108']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Topical application 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