Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-02 @ 4:51 AM
Study NCT ID:
NCT00808366
Status:
UNKNOWN
Last Update Posted:
2008-12-15
First Post:
2008-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of RV4104A Ointment in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007641', 'term': 'Keratolytic Agents'}, {'id': 'D000935', 'term': 'Antifungal Agents'}], 'ancestors': [{'id': 'D003879', 'term': 'Dermatologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-12-12', 'studyFirstSubmitDate': '2008-12-12', 'studyFirstSubmitQcDate': '2008-12-12', 'lastUpdatePostDateStruct': {'date': '2008-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by a blinded imaging expert's panel on the basis of standardized photographs", 'timeFrame': 'D21'}], 'secondaryOutcomes': [{'measure': 'Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by the investigator on the basis of clinical evaluation', 'timeFrame': 'D21'}, {'measure': 'Patient self-assessment', 'timeFrame': 'D21, D77, D105'}, {'measure': 'Clinical cure', 'timeFrame': 'D77, D105'}, {'measure': 'Mycological cure', 'timeFrame': 'D105'}, {'measure': 'Complete cure of onychomycosis', 'timeFrame': 'D105'}, {'measure': 'Local tolerability', 'timeFrame': 'D7, D21'}, {'measure': 'Adverse Event reporting', 'timeFrame': 'Throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail)\n* Target nail plate showing ≥ 12.5% of clinically infected area\n* Patient must have at least 2 mm of the proximal end of the target nail free of infection\n* Target nail infection due exclusively to a dermatophyte (from both positive direct microscopy examination and positive fungal culture as reported by the central mycological laboratory)\n\nExclusion Criteria:\n\n* Patient with more than 2 affected toenails\n* Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s)\n* Patient with moccasin-type tinea pedis\n* Patient who has received systemic antifungal therapy or topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to the feet or toenails within 2 months prior to screening visit'}, 'identificationModule': {'nctId': 'NCT00808366', 'briefTitle': 'Efficacy and Safety of RV4104A Ointment in Onychomycosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Dermo Cosmetique'}, 'officialTitle': 'A Randomized, Parallel-Group, Multicentre, Open-Labelled, Active-Controlled Study to Assess the Efficacy, Safety and Tolerability of RV4104A Ointment Versus Bifonazole-Urea Ointment for the Complete Removal of the Clinically Infected Nail Plate Area in Patients With Toenail Onychomycosis', 'orgStudyIdInfo': {'id': 'RV4104A2007593'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RV4104A ointment', 'interventionNames': ['Drug: Keratolytic/Antifungal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bifonazole-urea ointment', 'interventionNames': ['Drug: Keratolytic/Antifungal']}], 'interventions': [{'name': 'Keratolytic/Antifungal', 'type': 'DRUG', 'description': 'Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.', 'armGroupLabels': ['RV4104A ointment']}, {'name': 'Keratolytic/Antifungal', 'type': 'DRUG', 'description': 'Initial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.', 'armGroupLabels': ['bifonazole-urea ointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hôpital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Marine Maigret, PhD', 'role': 'CONTACT', 'email': 'marine.maigret@pierre-fabre.com', 'phone': '+33.5.62.48.85.92'}], 'overallOfficials': [{'name': 'Carle PAUL, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Purpan, Toulouse - FRANCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Dermo Cosmetique', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Anne-Marie Schmitt, MD', 'oldOrganization': 'Pierre Fabre Dermo Cosmetique'}}}}