Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-20 @ 12:17 AM
Study NCT ID:
NCT02466867
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2014-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014005', 'term': 'Tinea'}], 'ancestors': [{'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': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2016-10-27', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2014-10-29', 'dispFirstSubmitQcDate': '2016-10-27', 'studyFirstSubmitQcDate': '2015-06-04', 'dispFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis', 'timeFrame': '2 weeks', 'description': 'AUC0-24, Cmax, AUC0-24/D, Cmax/D, AUCt,ss, Cmax,ss, AUCt,,ss/D, Cmax,ss/D'}], 'secondaryOutcomes': [{'measure': 'Evaluate plasma PK single and multiple dose PK variables', 'timeFrame': '2 weeks', 'description': 'tmax and tmax,ss'}, {'measure': 'Evaluate trough plasma PK concentration', 'timeFrame': '2 weeks', 'description': 'Ctrough, ttrough,max, Ctrough,max'}, {'measure': 'Evaluate urine PK single and multiple dose variables', 'timeFrame': '2 weeks', 'description': 'Ae0-24, fe, CLR, AEt,ss'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ringworm'], 'conditions': ['Tinea Corporis']}, 'descriptionModule': {'briefSummary': 'This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or females 2 to 11 years, 11 months of any race. Females of child producing age (started menarche) must have a negative urine pregnancy test.\n* Presence of tinea corporis characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area.\n* KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected of the overall severity.\n* Subjects must be in good health and free from clinically significant disease that might interfere with the study evaluations.\n\nExclusion Criteria:\n\n* Tinea infection of the scalp, face, groin, and/or feet.\n* A life-threatening condition (ex. autoimmune deficiency syndrome, cancer) within the last 6 months\n* Subject with abnormal findings-physically or laboratory- that considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.\n* Subjects with a known hypersensitivity or other contradictions to study medications or their components.'}, 'identificationModule': {'nctId': 'NCT02466867', 'briefTitle': 'An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftin® (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis', 'orgStudyIdInfo': {'id': 'MUS90200_4025_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naftin® Cream, 2% (younger pediatric cohort)', 'description': 'Subject aged 2 years to 5 years, 11 months with tinea corporis', 'interventionNames': ['Drug: Naftin® Cream, 2% (younger pediatric cohort)']}, {'type': 'EXPERIMENTAL', 'label': 'Naftin® Cream, 2% (older pediatric cohort)', 'description': 'Subject aged 6 years to 11 years, 11 months with tinea corporis', 'interventionNames': ['Drug: Naftin® Cream, 2% (older pediatric cohort)']}], 'interventions': [{'name': 'Naftin® Cream, 2% (younger pediatric cohort)', 'type': 'DRUG', 'description': 'Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months.', 'armGroupLabels': ['Naftin® Cream, 2% (younger pediatric cohort)']}, {'name': 'Naftin® Cream, 2% (older pediatric cohort)', 'type': 'DRUG', 'description': 'Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months.', 'armGroupLabels': ['Naftin® Cream, 2% (older pediatric cohort)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'Merz Investigative Site#001261', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Merz Investigative Site#180001', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'San Pedro Sula', 'country': 'Honduras', 'facility': 'Merz Investigative Site #504001', 'geoPoint': {'lat': 15.50585, 'lon': -88.02588}}], 'overallOfficials': [{'name': 'Alan B. Fleischer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merz North America, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz North America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}