Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT02644551
Status:
UNKNOWN
Last Update Posted:
2017-04-26
First Post:
2015-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of CELEXT07 in the Treatment of Toenail 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': 'D000077768', 'term': 'Ciclopirox'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011728', 'term': 'Pyridones'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2015-12-29', 'studyFirstSubmitQcDate': '2015-12-30', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks', 'timeFrame': 'week 52', 'description': 'Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes.\n\nand no residual involvement of the target toenail. The complete cure is a composite binary variable defined as "Yes" if:\n\n* Mycological cure (negative KOH and negative culture for dermatophytes) and\n* No residual involvement of the target toenail "No" if otherwise'}], 'secondaryOutcomes': [{'measure': 'Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks.', 'timeFrame': 'week 52', 'description': 'Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and \\<= 10% residual involvement of the target toenail.Clinical effectiveness is a composite binary variable defined as "Yes" if\n\n* Mycological cure (negative KOH and negative culture for dermatophytes) and ◦= 10% residual involvement of the target toenail "No" if otherwise'}, {'measure': 'Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 52 Weeks.', 'timeFrame': 'week 52', 'description': 'Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.\n\nMycological cure is a composite binary variable defined as "Yes"if :\n\n* Negative microscopy and\n* Negative culture for dermatophytes "No" if otherwise.'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'week 52'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'This will be an interventional safety and efficacy study of CELENT07 when used as a topical treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. This is randomized, double-blind, parallel design, placebo and active controlled study in patients with mild to moderate toenail distal lateral subungual onychomycosis (DLSO) (n=120). Subjects will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or PENLAC®, daily for 52 weeks. Efficacy assessments will include complete cure, mycologic cure and clinical efficacy and safety and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects are eligible to be included in the study only if they meet all of the following criteria:\n\n1. Age \\> 18.\n2. Clinically diagnosed onychomycosis of the target nail.\n3. Presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected.\n4. Has a positive KOH examination from the target nail.\n5. Has a positive dermatophyte culture from the target nail.\n6. Written informed consent obtained.\n7. Subject agreed to follow the protocol.\n\nExclusion Criteria\n\nSubjects will be excluded from the study if they meet any of the following criteria:\n\n1. Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug.\n2. Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis.\n3. Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit.\n4. Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.\n5. Inability to understand and comply with the instructions of the study\n6. Patients less than age 18\n7. Individuals with known allergy/hypersensitivity to Thuja occidentalis, Chelidonium majus, Eucalyptus citriodora, Tea tree or Thymus vulgaris.'}, 'identificationModule': {'nctId': 'NCT02644551', 'briefTitle': 'The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis', 'organization': {'class': 'INDUSTRY', 'fullName': '9305-9954 Quebec Inc'}, 'officialTitle': 'The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis: a Phase 2, Randomized, Double-blind Study', 'orgStudyIdInfo': {'id': 'CELEXT07-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CELEXT07', 'description': 'suspension that is applied topically to the infected nail(s) daily.', 'interventionNames': ['Drug: CELEXT07']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo is a suspension that simulates the physical properties of the experimental agent CELEXT07. It is applied topically to the infected nail(s) daily.', 'interventionNames': ['Other: vehicle solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Penlac', 'description': 'Is a standard of care for the condition and is applied topically to the infected nail(s) daily.', 'interventionNames': ['Drug: Penlac']}], 'interventions': [{'name': 'CELEXT07', 'type': 'DRUG', 'armGroupLabels': ['CELEXT07']}, {'name': 'Penlac', 'type': 'DRUG', 'otherNames': ['topical Penlac nail lacquer'], 'armGroupLabels': ['Penlac']}, {'name': 'vehicle solution', 'type': 'OTHER', 'otherNames': ['placebo'], 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1X 2B3', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'William Lee', 'role': 'CONTACT', 'email': 'drwlee@hotmail.com', 'phone': '514 254-5000'}], 'facility': 'Clinique podiatrique de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Wil Lee, DPM, AACFAS', 'role': 'CONTACT', 'email': 'drwlee@hotmail.com', 'phone': '514-254-5000'}, {'name': 'Liza Lymberopoulos', 'role': 'CONTACT', 'phone': '514-254-5000'}], 'overallOfficials': [{'name': 'Céline Devaux, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '9305-9954 Quebec Inc'}, {'name': 'Guy Chamberland, M.Sc., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': '9305-9954 Quebec Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '9305-9954 Quebec Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}