Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT07245667
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014008', 'term': 'Tinea Pedis'}], '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': 'D005533', 'term': 'Foot Dermatoses'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects with a Complete Cure at Week 4', 'timeFrame': 'Week 4', 'description': 'Primary Efficacy Endpoint: Effective treatment, defined as mycological cure, based on a negative potassium hydroxide (KOH) test at week 4.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tinea pedis', 'athletes foot'], 'conditions': ['Tinea Pedis']}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07245667', 'briefTitle': 'Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Propedix, Inc.'}, 'officialTitle': 'Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis', 'orgStudyIdInfo': {'id': 'PRO-TP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tolnaftate Stick Formula A', 'description': '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.', 'interventionNames': ['Drug: 1% Tolnaftate Stick Formula A']}, {'type': 'EXPERIMENTAL', 'label': 'Tolnaftate Stick Formula B', 'description': '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.', 'interventionNames': ['Drug: 1% Tolnaftate Stick Formula B']}, {'type': 'EXPERIMENTAL', 'label': 'Tolnaftate Stick Formula C', 'description': 'Topical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks.', 'interventionNames': ['Drug: 1% Tolnaftate Stick Formula C']}], 'interventions': [{'name': '1% Tolnaftate Stick Formula A', 'type': 'DRUG', 'description': 'Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks.', 'armGroupLabels': ['Tolnaftate Stick Formula A']}, {'name': '1% Tolnaftate Stick Formula B', 'type': 'DRUG', 'description': 'Topical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks.', 'armGroupLabels': ['Tolnaftate Stick Formula B']}, {'name': '1% Tolnaftate Stick Formula C', 'type': 'DRUG', 'description': 'Topical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days.', 'armGroupLabels': ['Tolnaftate Stick Formula C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01701', 'city': 'Framingham', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Prinicipal Investigator', 'role': 'CONTACT', 'email': 'clinicalresearch@propedix.com', 'phone': '508-872-2220'}], 'facility': 'Kuchnir Dermatology and Dermatological Surgery', 'geoPoint': {'lat': 42.27926, 'lon': -71.41617}}, {'zip': '01757', 'city': 'Milford', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Prinicipal Investigator', 'role': 'CONTACT', 'email': 'clinicalresearch@propedix.com', 'phone': '508-478-2610'}], 'facility': 'Kuchnir Dermatology and Dermatological Surgery', 'geoPoint': {'lat': 42.13982, 'lon': -71.51617}}], 'centralContacts': [{'name': 'Prinicipal Investigator', 'role': 'CONTACT', 'email': 'cschanbacher@propedix.com', 'phone': '617-869-0126'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared outside the study team because this is a small study designed for internal evaluation of formulation performance and tolerability. Data will be presented only in aggregated, de-identified form in any publications or presentations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Propedix, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}