{ "FullStudy":{ "Rank":217564, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519752", "OrgStudyIdInfo":{ "OrgStudyId":"OXZC 1102" }, "Organization":{ "OrgFullName":"Taro Pharmaceuticals USA", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis", "OfficialTitle":"A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site, Study Comparing Oxiconazole Nitrate Cream 1% (Taro Pharmaceuticals,Inc) to Oxistat® (Oxiconazole Nitrate Cream) Cream 1% (PharmaDerma) in the Treatment of Tinea Pedis" }, "StatusModule":{ "StatusVerifiedDate":"January 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 19, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 22, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Taro Pharmaceuticals USA", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is effective for the treatment of patients with moderate to severe Tinea pedis." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Tinea Pedis" ] }, "KeywordList":{ "Keyword":[ "Tinea Pedis" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"661", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Oxiconazole Nitrate Cream 1%", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Oxiconazole Nitrate Cream 1%" ] } },{ "ArmGroupLabel":"Oxiconazole Nitrate Cream 1% (Oxistat®)", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Oxiconazole Nitrate Cream 1% (Oxistat®)" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Oxiconazole Nitrate Cream 1%", "InterventionDescription":"Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Oxiconazole Nitrate Cream 1%" ] } },{ "InterventionType":"Drug", "InterventionName":"Oxiconazole Nitrate Cream 1% (Oxistat®)", "InterventionDescription":"Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Oxiconazole Nitrate Cream 1% (Oxistat®)" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Placebo applied to affected area once a day for 28 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Therapeutic Cure", "PrimaryOutcomeDescription":"Clinical & Mycological Cure at 6 weeks", "PrimaryOutcomeTimeFrame":"Day 42" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Clinical Cure", "SecondaryOutcomeDescription":"Proportion of patients considered a clinical cure at 6 weeks", "SecondaryOutcomeTimeFrame":"Day 42" },{ "SecondaryOutcomeMeasure":"Mycological Cure", "SecondaryOutcomeDescription":"Proportion of patients with both KOH & culture negative at 6 weeks", "SecondaryOutcomeTimeFrame":"Day 42" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale or non-pregnant, non-lactating female, 12 years of age or older.\nSigned informed consent form, which meets all criteria of current FDA regulations\nIf female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study {e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives)and (must have used the same product for at least 30 days prior to the study start and use the same product throughout the duration of the study), transdermal or implanted hormonal contraceptives}\nA confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot. (the non-interdigital lesions should not be hyperkeratotic i.e., characteristic of moccasin).\nThe presence of tinea pedis infection, confirm by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination.\n\nExclusion Criteria:\n\nFemales who are pregnant, or lactating or likely to become pregnant during the study.\nAny known hypersensitivity to oxiconazole nitrate or other antifungal agents.\nPatients with a past history of tinea pedis infections with a lack of response to antifungal therapy (i.e. recurrent tinea pedis, more than 3 infections in the past 12 months, which were unresponsive to previous antifungal therapy).\nParticipation in a research study in the past 30 days prior to screening/randomization.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"12 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "United States" ] } }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"C000022155", "InterventionMeshTerm":"Oxiconazole" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000935", "InterventionAncestorTerm":"Antifungal Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M263911", "InterventionBrowseLeafName":"Oxiconazole", "InterventionBrowseLeafAsFound":"Oxiconazole", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2835", "InterventionBrowseLeafName":"Antifungal Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M4835", "InterventionBrowseLeafName":"Clotrimazole", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M10379", "InterventionBrowseLeafName":"Miconazole", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000014005", "ConditionMeshTerm":"Tinea" },{ "ConditionMeshId":"D000014008", "ConditionMeshTerm":"Tinea Pedis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000003881", "ConditionAncestorTerm":"Dermatomycoses" },{ "ConditionAncestorId":"D000012874", "ConditionAncestorTerm":"Skin Diseases, Infectious" },{ "ConditionAncestorId":"D000007239", "ConditionAncestorTerm":"Infection" },{ "ConditionAncestorId":"D000009181", "ConditionAncestorTerm":"Mycoses" },{ "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" },{ "ConditionAncestorId":"D000005533", "ConditionAncestorTerm":"Foot Dermatoses" },{ "ConditionAncestorId":"D000005534", "ConditionAncestorTerm":"Foot Diseases" },{ "ConditionAncestorId":"D000011537", "ConditionAncestorTerm":"Pruritus" },{ "ConditionAncestorId":"D000012877", "ConditionAncestorTerm":"Skin Manifestations" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M15345", "ConditionBrowseLeafName":"Tinea", "ConditionBrowseLeafAsFound":"Tinea", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15348", "ConditionBrowseLeafName":"Tinea Pedis", "ConditionBrowseLeafAsFound":"Tinea Pedis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5659", "ConditionBrowseLeafName":"Dermatomycoses", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14260", "ConditionBrowseLeafName":"Skin Diseases, Infectious", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10719", "ConditionBrowseLeafName":"Mycoses", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7240", "ConditionBrowseLeafName":"Foot Dermatoses", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7241", "ConditionBrowseLeafName":"Foot Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12979", "ConditionBrowseLeafName":"Pruritus", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14263", "ConditionBrowseLeafName":"Skin Manifestations", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"BC05", "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases" } ] } } } } } }