Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT00777868
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2008-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014009', 'term': 'Onychomycosis'}], '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': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-20', 'studyFirstSubmitDate': '2008-10-20', 'studyFirstSubmitQcDate': '2008-10-20', 'lastUpdatePostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in area of infected nail', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in mycological results', 'timeFrame': '9 months'}]}, 'conditionsModule': {'conditions': ['Onychomycosis']}, 'referencesModule': {'references': [{'pmid': '23377392', 'type': 'DERIVED', 'citation': 'Tschen EH, Bucko AD, Oizumi N, Kawabata H, Olin JT, Pillai R. Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study. J Drugs Dermatol. 2013 Feb;12(2):186-92.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of onychomycosis of the target toenail\n* A positive fungal culture from the target toenail\n\nExclusion Criteria:\n\n* Any disease or condition that might cause nail abnormalities or may interfere with clinical evaluations\n* Presence of tinea pedis (athletes foot)\n* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study'}, 'identificationModule': {'nctId': 'NCT00777868', 'briefTitle': 'A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dow Pharmaceutical Sciences'}, 'orgStudyIdInfo': {'id': 'DPSI-IDP-108-P2-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Low Strength IDP-108']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: High Strength IDP-108']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: High Strength IDP-108 under occlusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'Low Strength IDP-108', 'type': 'DRUG', 'description': 'Topical application once a day for 9 months', 'armGroupLabels': ['1']}, {'name': 'High Strength IDP-108', 'type': 'DRUG', 'description': 'Topical application once a day for 9 months', 'armGroupLabels': ['2']}, {'name': 'High Strength IDP-108 under occlusion', 'type': 'DRUG', 'description': 'Topical application once a day for 9 months', 'armGroupLabels': ['3']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Topical application once a day for 9 months', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CP31205', 'city': 'Chihuahua City', 'state': 'Chihuahua', 'country': 'Mexico', 'facility': 'Unidad de Investigación en Salud', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'zip': 'CP54055', 'city': 'Mexico City', 'state': 'Federal District', 'country': 'Mexico', 'facility': 'Clinical Research Institute', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'state': 'Federal District', 'country': 'Mexico', 'facility': 'Hospital Central Militar', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': 'CP 06726', 'city': 'México', 'state': 'Federal District', 'country': 'Mexico', 'facility': 'Hospital General de México', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': 'CP45190', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio"', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': 'CP45200', 'city': 'Zapopan', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Hospital Dr. Ángel Leaño', 'geoPoint': {'lat': 20.72111, 'lon': -103.38742}}, {'zip': 'CP64000', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'MIRC/OCA Hospital', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': 'CP64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Centro de Dermatología de Monterrey', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': 'CP64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Hospital Universitario "José E. González"', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': 'CP 78240', 'city': 'San Luis Potosí City', 'state': 'San Luis Potosí', 'country': 'Mexico', 'facility': 'Hospital Ignacio Morones Prieto SLP', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow Pharmaceutical Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}