[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611829":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":38,"overallOfficials":13,"centralContacts":52,"locations":58,"responsibleParty":88,"collaborators":13,"id":90,"slug":13,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":13,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":13,"enrollmentInfo":99,"targetDuration":13,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":61,"whyStopped":13,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Propedix, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Subjects with a Complete Cure at Week 4","Primary Efficacy Endpoint: Effective treatment, defined as mycological cure, based on a negative potassium hydroxide (KOH) test at week 4.","Week 4",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","To evaluate the efficacy and safety of 1% tolnaftate formulations delivered through novel stick-based vehicles in the treatment of subjects with potassium hydroxide (KOH)-positive tinea pedis.",[22,28,33],{"label":23,"type":24,"description":25,"interventionNames":26},"Tolnaftate Stick Formula A","EXPERIMENTAL","Participants will receive Formula A, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks.",[27],"Drug: 1% Tolnaftate Stick Formula A",{"label":29,"type":24,"description":30,"interventionNames":31},"Tolnaftate Stick Formula B","Participants will receive Formula B, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks.",[32],"Drug: 1% Tolnaftate Stick Formula B",{"label":34,"type":24,"description":35,"interventionNames":36},"Tolnaftate Stick Formula C","Topical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks.",[37],"Drug: 1% Tolnaftate Stick Formula C",[39,44,48],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":13},"DRUG","1% Tolnaftate Stick Formula A","Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks.",[23],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":13},"1% Tolnaftate Stick Formula B","Topical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks.",[29],{"type":40,"name":49,"description":50,"armGroupLabels":51,"otherNames":13},"1% Tolnaftate Stick Formula C","Topical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days.",[34],[53],{"name":54,"role":55,"phone":56,"phoneExt":13,"email":57},"Prinicipal Investigator","CONTACT","617-869-0126","cschanbacher@propedix.com",[59,77],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Kuchnir Dermatology and Dermatological Surgery","RECRUITING","Framingham","Massachusetts","01701","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-71.41617,42.27926,{"lat":71,"lon":70},[74],{"name":54,"role":55,"phone":75,"phoneExt":13,"email":76},"508-872-2220","clinicalresearch@propedix.com",{"facility":60,"status":61,"city":78,"state":63,"zip":79,"country":65,"countryCode":66,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Milford","01757",{"type":68,"coordinates":81},[82,83],-71.51617,42.13982,{"lat":83,"lon":82},[86],{"name":54,"role":55,"phone":87,"phoneExt":13,"email":76},"508-478-2610",{"type":89,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100611829",false,"NCT07245667","Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study","Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis","Inclusion Criteria:\n\n* Male or female, aged 16 or above\n* Clinical diagnosis of tinea pedis (For Cohort 4, positive symptomology is acceptable)\n* Confirmation of diagnosis with positive potassium hydroxide (KOH) microscopy (For Cohort 4, a negative KOH test is acceptable)\n* Signed and dated informed consent form\n* Willingness to comply with study protocol and availability for the duration of the study\n\nExclusion Criteria:\n\n* Diagnosis of moccasin-type tinea pedis\n* Presence of serous exudate or pus\n* Treatment with a topical antifungal in the past 2 weeks\n* Treatment with a systemic antifungal in the past 4 weeks\n* Concurrent immunosuppressive or antimicrobial therapy\n* Liver disease\n* Pregnancy or breastfeeding\n* Use any other antifungal therapy during trial or within three months of starting the trial\n* Known hypersensitivity to any ingredients of trial agents\n* Patients with a current diagnosis of diabetes or neuropathy",true,"ALL","16 Years",{"count":100,"type":101},150,"ESTIMATED","INTERVENTIONAL",[104],"PHASE2","This study is designed to evaluate the safety and effectiveness of multiple 1% tolnaftate formulations delivered through novel stick-based vehicles in individuals with tinea pedis (athlete's foot).",[107],"Tinea Pedis",[109,110],"tinea pedis","athletes foot","2025-11-23",{"date":113,"type":114},"2025-11-28","ACTUAL",{"date":116,"type":114},"2024-12-30",{"date":118,"type":101},"2026-02",{"name":5,"class":6},2]