Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT04883593
Status:
COMPLETED
Last Update Posted:
2021-05-12
First Post:
2021-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital 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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects with complete cure at Week 6 (+/- 4 days) following treatment (study day 38-46)', 'timeFrame': 'Baseline to Week 6 Visit', 'description': 'To evaluate safety and efficacy of TA103'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tinea Pedis']}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the safety and efficacy of TA103 in the treatment of tinea pedis.', 'detailedDescription': 'A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing TA103 and the placebo control in the treatment of tinea pedis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or non pregnant female aged ≥ 18 years\n* Subjects must have provided IRB approved written informed consent\n* Subjects must have clinical diagnosis of interdigital 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 tinea pedis moccasin).\n\nExclusion Criteria:\n\n* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.\n* Subjects with a history of hypersensitivity or allergy to any of the study medication ingredients and its excipients.\n* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.'}, 'identificationModule': {'nctId': 'NCT04883593', 'briefTitle': 'A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries, Inc.'}, 'officialTitle': 'A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TA103 and Placebo Control in the Treatment of Tinea Pedis.', 'orgStudyIdInfo': {'id': 'TA103-2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TA103', 'description': 'The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.', 'interventionNames': ['Drug: TA103']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.', 'interventionNames': ['Drug: Placebo Control']}], 'interventions': [{'name': 'TA103', 'type': 'DRUG', 'otherNames': ['Test Product'], 'description': 'The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.', 'armGroupLabels': ['TA103']}, {'name': 'Placebo Control', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28217', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Catawba Research, LLC', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Zaidoon A. Al-Zubaidy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Catawba Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}