Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
Study NCT ID:
NCT03897257
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2019-03-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Five Arms:\n\n* 3 Arms of Monotherapy : UHE-103A1 cream (Drug A low dose concentration) or UHE-103A2 cream (Drug A high concentration) or UHE-103B cream (Drug B comparator)\n* 2 Arms of combination therapy: UHE-103A1B cream (Drug A low dose + Drug B), or UHE-103A2B cream (Drug A high dose + Drug B)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'dispFirstSubmitDate': '2020-06-09', 'completionDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2019-03-28', 'dispFirstSubmitQcDate': '2021-10-26', 'studyFirstSubmitQcDate': '2019-03-28', 'dispFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Cure at End of Study', 'timeFrame': 'Day 43', 'description': 'Proportion of subjects with Complete Cure (negative fungal test \\& no clinical disease-induced signs and symptoms) at end of study (EOS).'}], 'secondaryOutcomes': [{'measure': 'Effective treatment', 'timeFrame': 'Day 43', 'description': 'Proportion of subjects with Effective Treatment (negative fungal test \\& no to mild clinical disease-induced signs and symptoms) at EOS.'}, {'measure': 'Mycological Cure', 'timeFrame': 'Day 43', 'description': 'Proportion of subjects with Mycological Cure (negative fungal test) at EOS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tinea Pedis']}, 'descriptionModule': {'briefSummary': 'The study is being done to determine and compare the safety and effectiveness of an investigational combination therapy (low and high concentrations) versus mono-therapy (low and high concentrations) or mono-therapy (fixed concentration) in subjects with moccasin type tinea pedis.', 'detailedDescription': 'UHE-103 cream is an investigational combination drug to treat moccasin type tinea pedis, a fungal infection that affects the feet and toes. Eligible subjects will be assigned to one of the 5 possible treatment groups and participate for a total of 6 weeks. Subjects will apply their assigned test drug twice daily for 2 weeks. Each subject will then be assessed for safety and efficacy at week 4 and week 6. There will be a total of 5 clinic visits: 1 screening/baseline visit (Day 1), 2 treatment visits (Days 8 and 15), and 2 follow-up visits (Days 29 and 43).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant female, 16 years of age or older.\n* Clinical diagnosis of moccasin type tinea pedis\n* Microscopic evidence (positive KOH) of the presence of fungi\n* Provided written informed consent/assent\n* In general good health\n\nExclusion Criteria:\n\n* Pregnant or lactating or planning to get pregnant while on the study\n* Has concurrent tinea infection (e.g., tinea versicolor, tinea cruris)\n* Other skin disease which might interfere with the evaluation of tinea pedis\n* History of diabetes mellitus or is immunocompromised\n* Currently enrolled in an investigational drug or device study\n* Used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Study Day 1)/Baseline\n\nOther protocol defined inclusion or exclusion criteria assessed by the study staff may apply.'}, 'identificationModule': {'nctId': 'NCT03897257', 'briefTitle': 'A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Therapeutics, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blinded, Parallel Group Comparison Study of the Safety and Efficacy of UHE-103 in Subjects With Moccasin-Type Tinea Pedis', 'orgStudyIdInfo': {'id': '146-9252-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UHE-103A1 cream', 'description': 'Topical cream applied twice daily for 2 weeks.', 'interventionNames': ['Drug: UHE-103A1 cream']}, {'type': 'EXPERIMENTAL', 'label': 'UHE-103A2 cream', 'description': 'Topical cream applied twice daily for 2 weeks.', 'interventionNames': ['Drug: UHE-103A2 cream']}, {'type': 'EXPERIMENTAL', 'label': 'UHE-103B cream', 'description': 'Topical cream applied twice daily for 2 weeks.', 'interventionNames': ['Drug: UHE-103B cream']}, {'type': 'EXPERIMENTAL', 'label': 'UHE-103A1B cream', 'description': 'Topical cream applied twice daily for 2 weeks.', 'interventionNames': ['Drug: UHE-103A1B cream']}, {'type': 'EXPERIMENTAL', 'label': 'UHE-103A2B cream', 'description': 'Topical cream applied twice daily for 2 weeks.', 'interventionNames': ['Drug: UHE-103A2B cream']}], 'interventions': [{'name': 'UHE-103A1 cream', 'type': 'DRUG', 'description': 'Investigational mono-therapy cream (containing drug A \\[low dose\\]). Drug A is an antifungal agent.', 'armGroupLabels': ['UHE-103A1 cream']}, {'name': 'UHE-103A2 cream', 'type': 'DRUG', 'description': 'Investigational mono-therapy cream (containing drug A \\[low dose\\]). Drug A is an antifungal agent.', 'armGroupLabels': ['UHE-103A2 cream']}, {'name': 'UHE-103B cream', 'type': 'DRUG', 'description': 'Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent.', 'armGroupLabels': ['UHE-103B cream']}, {'name': 'UHE-103A1B cream', 'type': 'DRUG', 'description': 'Investigational combination-therapy cream (containing drug A \\[low dose antifungal\\] + drug B \\[keratolytic\\]).', 'armGroupLabels': ['UHE-103A1B cream']}, {'name': 'UHE-103A2B cream', 'type': 'DRUG', 'description': 'Investigational combination-therapy cream (containing drug A \\[high dose antifungal\\] + drug B \\[keratolytic\\]).', 'armGroupLabels': ['UHE-103A2B cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Site 03', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32935', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 12', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 06', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33162', 'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 09', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '60008', 'city': 'Rolling Meadows', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site 07', 'geoPoint': {'lat': 42.08419, 'lon': -88.01313}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Site 11', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Site 04', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 01', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77055', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 02', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 10', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Site 05', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '00739', 'city': 'Cidra', 'country': 'Puerto Rico', 'facility': 'Site 08', 'geoPoint': {'lat': 18.17579, 'lon': -66.16128}}], 'overallOfficials': [{'name': 'Marietta Radona, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}