Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-28 @ 7:46 AM
Study NCT ID:
NCT00771732
Status:
UNKNOWN
Last Update Posted:
2008-10-13
First Post:
2008-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Light Therapy to Treat Toe Nail Fungus
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': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-10-10', 'studyFirstSubmitDate': '2008-07-07', 'studyFirstSubmitQcDate': '2008-10-10', 'lastUpdatePostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical improvement', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'mycological negative', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['toe nail fungus'], 'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'To see if four sessions of light therapy successfully treats nail fungus.', 'detailedDescription': 'This study is a one year study which includes four treatment sessions of light therapy looking for clinical and mycological improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* toe nail fungus, not infolving lunula\n* between ages 18-70 years old\n\nExclusion Criteria:\n\n* not on systemic anti-fungal medications'}, 'identificationModule': {'nctId': 'NCT00771732', 'briefTitle': 'Using Light Therapy to Treat Toe Nail Fungus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nomir Medical Technologies'}, 'officialTitle': 'Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study', 'orgStudyIdInfo': {'id': '09.002'}, 'secondaryIdInfos': [{'id': '07-301'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Light therapy', 'interventionNames': ['Device: light therapy']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': '6 minute "session" given with machine "off"', 'interventionNames': ['Device: light therapy']}], 'interventions': [{'name': 'light therapy', 'type': 'DEVICE', 'otherNames': ['laser threapy'], 'description': '6 minute light therapy', 'armGroupLabels': ['1']}, {'name': 'light therapy', 'type': 'DEVICE', 'otherNames': ['No therapy/machine is "off"'], 'description': 'combination of wavelengths', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02452', 'city': 'Southborough', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paula Angelini, DPM', 'role': 'CONTACT', 'email': 'Paula.Angelini@southboromedicalgroup.com', 'phone': '617-901-6421'}, {'name': 'Mary Oster', 'role': 'CONTACT', 'email': 'm.oster@nomirmedical.com', 'phone': '508-524-4632'}], 'facility': 'Paula Angelini, DPM', 'geoPoint': {'lat': 42.30565, 'lon': -71.52451}}], 'centralContacts': [{'name': 'Mary E Oster', 'role': 'CONTACT', 'email': 'm.oster@nomirmedical.com', 'phone': '781-893-1000'}, {'name': 'Alan Robbins, M.D.', 'role': 'CONTACT', 'email': 'alanhrobbins@comcast.com', 'phone': '781-893-1000'}], 'overallOfficials': [{'name': 'Alan Robbins, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Nomir Medical Technologies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nomir Medical Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Nomir Medical Technologies', 'oldOrganization': 'Nomir Medical Technologies'}}}}