Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-01-28 @ 9:07 PM
Study NCT ID:
NCT01666002
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2012-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tangy@stanford.edu', 'phone': '650-723-6316', 'title': 'Jean Tang MD PhD, assistant professor', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': '1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.\n2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.\n\nLaser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser\n\nNo patients reported complications or adverse events after 2 sessions.', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '1. st visit: For the control group, no treatment will be given.\n2. nd visit: 2 weeks after initial visit, patient will be seen for second visit', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.\n2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.\n\nLaser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser\n\nAfter 3 months, 4 of 12 patients (33%) in the laser group had negative fungal cultures. Of the 4 patients in the laser group with baseline cultures positive for a non-dermatophyte mold, 2 (50%) had negative fungal cultures. After 3 months of observation, 2 of 10 (20%) control subjects had negative cultures. Of the 3 patients in the control group with baseline cultures positive for a non-dermatophyte mold, 1 (33%) had a negative fungal culture. There was no significant difference in the percentage of patients with negative nail cultures between laser versus control groups (P = .49).'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1. st visit: For the control group, no treatment will be given.\n2. nd visit: 2 weeks after initial visit, patient will be seen for second visit'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proximal Clearance of Fungus on Nail', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'units': 'nails', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.\n2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.\n\nLaser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1. st visit: For the control group, no treatment will be given.\n2. nd visit: 2 weeks after initial visit, patient will be seen for second visit'}], 'classes': [{'categories': [{'measurements': [{'value': '0.44', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': "The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients' toenails, and confirmed by digital analysis of toenail photographs with ImageJ software.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'nails', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': '1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.\n2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.\n\nLaser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser\n\n42 patients were assessed and 27 met eligibility criteria of a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture.'}, {'id': 'FG001', 'title': 'Placebo', 'description': '1. st visit: For the control group, no treatment will be given.\n2. nd visit: 2 weeks after initial visit, patient will be seen for second visit'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'We enrolled adults (18-75 years) with a clinical diagnosis of onychomycosis from the dermatology clinic at Stanford between July and December 2011. The key inclusion criterion was a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture.', 'preAssignmentDetails': 'Patients were randomized following simple randomization procedures (computerized random number generator) in a 2:1 ratio into laser or control groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': '1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.\n2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.\n\nLaser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser'}, {'id': 'BG001', 'title': 'Placebo', 'description': '1. st visit: For the control group, no treatment will be given.\n2. nd visit: 2 weeks after initial visit, patient will be seen for second visit'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '14', 'groupId': 'BG000'}, {'value': '65', 'spread': '8', 'groupId': 'BG001'}, {'value': '59', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Sample size calculations (STATA 10, Stat Corp, College Station, TX) indicated that we needed to enroll 24 patients at a 2:1 ratio for 80% power to detect a minimal proximal nail plate difference of 2.5 mm in the 2 groups with a 2-sided alpha of 0.05.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-21', 'studyFirstSubmitDate': '2012-08-10', 'resultsFirstSubmitDate': '2014-12-16', 'studyFirstSubmitQcDate': '2012-08-15', 'lastUpdatePostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-21', 'studyFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Proximal Clearance of Fungus on Nail', 'timeFrame': '1 year', 'description': "The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients' toenails, and confirmed by digital analysis of toenail photographs with ImageJ software."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Onychomycosis']}, 'referencesModule': {'references': [{'pmid': '21250792', 'type': 'BACKGROUND', 'citation': 'Hochman LG. Laser treatment of onychomycosis using a novel 0.65-millisecond pulsed Nd:YAG 1064-nm laser. J Cosmet Laser Ther. 2011 Feb;13(1):2-5. doi: 10.3109/14764172.2011.552616. Epub 2011 Jan 21.'}, {'pmid': '17902014', 'type': 'BACKGROUND', 'citation': 'Vural E, Winfield HL, Shingleton AW, Horn TD, Shafirstein G. The effects of laser irradiation on Trichophyton rubrum growth. Lasers Med Sci. 2008 Oct;23(4):349-53. doi: 10.1007/s10103-007-0492-4. Epub 2007 Sep 28.'}, {'pmid': '22461276', 'type': 'BACKGROUND', 'citation': 'Landsman AS, Robbins AH. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure: some follow-up observations at 270 days. J Am Podiatr Med Assoc. 2012 Mar-Apr;102(2):169-71. doi: 10.7547/1020169.'}, {'pmid': '22453588', 'type': 'RESULT', 'citation': 'Kimura U, Takeuchi K, Kinoshita A, Takamori K, Hiruma M, Suga Y. Treating onychomycoses of the toenail: clinical efficacy of the sub-millisecond 1,064 nm Nd: YAG laser using a 5 mm spot diameter. J Drugs Dermatol. 2012 Apr;11(4):496-504.'}]}, 'descriptionModule': {'briefSummary': 'The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will compare the success rates of those receiving laser treatments with untreated patients. This study will provide a clinical basis for determining the relative effectiveness of an increasingly utilized treatment method.', 'detailedDescription': 'Current antifungal treatments have low cure rates and numerous side effects. A new treatment method, pulsed laser, has been purported to have high rates of treatment in a much shorter time frame than other treatments. While the treatment method has become increasingly popular, studies of its efficacy are few. The investigators hope to learn the cure rate of a novel treatment that is being used by more and more patients. This knowledge will be essential to physicians as they consider employing this new technology in their treatment methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have Onychomycosis on at least one toe.\n* Age 18 or older.\n* Consent to research use of their toenail clippings.\n\nExclusion Criteria:\n\n* Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs.\n* Pregnant female.\n* Age 75 or older.'}, 'identificationModule': {'nctId': 'NCT01666002', 'briefTitle': 'Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser', 'orgStudyIdInfo': {'id': 'Onycho-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': '1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.\n2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.', 'interventionNames': ['Device: Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)']}, {'type': 'NO_INTERVENTION', 'label': 'Placebo', 'description': '1. st visit: For the control group, no treatment will be given.\n2. nd visit: 2 weeks after initial visit, patient will be seen for second visit'}], 'interventions': [{'name': 'Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)', 'type': 'DEVICE', 'description': '0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Jean Tang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Tyler Hollmig, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Stanford University'}, {'name': 'Michael Henderson, BA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Dermatology', 'investigatorFullName': 'Jean Yuh Tang', 'investigatorAffiliation': 'Stanford University'}}}}