Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT00781820
Status:
COMPLETED
Last Update Posted:
2013-06-11
First Post:
2008-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 693}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-09', 'studyFirstSubmitDate': '2008-10-28', 'studyFirstSubmitQcDate': '2008-10-28', 'lastUpdatePostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative', 'timeFrame': '14 days after end of treatment (=visit 3)'}], 'secondaryOutcomes': [{'measure': 'Clinical cure rate', 'timeFrame': '14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)'}, {'measure': 'Culture negative', 'timeFrame': '14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)'}, {'measure': 'Microscopy negative', 'timeFrame': '14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)'}, {'measure': 'Relapse rate (overall cure at visit 3 but positive clinical or mycological findings at visit 4', 'timeFrame': '3 and 6 months after end of treatment (=visit 4 and 5)'}, {'measure': 'Mycological cure rate (microscopy + culture negative)', 'timeFrame': '3 and 6 months after end of treatment (=visit 4 and 5)'}, {'measure': 'Culture negative', 'timeFrame': '6 months after end of treatment (=visit 5)'}, {'measure': 'Incidence of adverse events', 'timeFrame': '2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bifonazole', 'Placebo', 'Urea', 'Nail fungus'], 'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'The study is focused to prove that the efficacy of a 1% Bifonazole cream is superior to a placebo cream after non-surgical nail ablation with a 40% urea paste.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of at least 18 years;\n* Positive clinical findings of onychomycosis according to the judgement of the investigator (e.g. thickening, discoloration, structural changes, misshaped nails);\n* Positive mycological findings (positive microscopy and positive culture with identification of pathogen) in material taken from affected nail sites before the start of treatment;\n* Nail mycosis with an affected nail area between 20% and 50% in the target nail,\n* Nail mycosis in not more than 3 nails (each nail not more than 50% infected area)\n\nExclusion Criteria:\n\n* Doubtful or negative mycological findings;\n* Proximal subungual onychomycosis (PSO);\n* Topical antimycotic treatment of feet or hands within 4 weeks prior to screening, topical treatment of onychomycosis of feet or hands within 12 weeks prior to screening;\n* Systemic antimycotic treatment within 12 weeks prior to screening;\n* Failure to treat tinea pedis/manus (diagnosed at screening) successfully with topical treatment between screening visit and visit 1 (baseline);\n* Tinea pedis/manus at visit 1 (baseline);\n* Uncontrolled diabetes mellitus\n* Psoriasis\n* Peripheral arterial disease\n* Chronic venous insufficiency;\n* Diabetic neuropathy;\n* History of hypersensitivity to bifonazole, or any other similar pharmacological agents or components of the products;\n* Known sensitivity to plasters.'}, 'identificationModule': {'nctId': 'NCT00781820', 'briefTitle': 'Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Double-blind, Randomized, Multicenter, Placebo- Controlled Phase 3 Trial to Prove the Superiority of Bifonazole vs. Placebo After 4 Weeks of Onychomycosis Treatment/ as a Follow-up of a 2 Weeks Treatment of Non-surgical Nail Ablation of Diseased Nail Matrix With 40% Urea Paste', 'orgStudyIdInfo': {'id': '12999'}, 'secondaryIdInfos': [{'id': '2008-003215-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: Placebo cream']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Bifonazole cream 1%']}], 'interventions': [{'name': 'Bifonazole cream 1%', 'type': 'DRUG', 'description': '1 squeeze of Bifonazole cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste', 'armGroupLabels': ['Arm 1']}, {'name': 'Placebo cream', 'type': 'DRUG', 'description': '1 squeeze of Placebo cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste', 'armGroupLabels': ['Arm 2']}]}, 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