Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2026-01-04 @ 12:30 AM
Study NCT ID:
NCT05260450
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2022-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fungal infection status in nail clippings measured by microscopy after laser treatment.', 'timeFrame': 'Approximately 10 minutes after treatment', 'description': 'The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy after therapy.'}, {'measure': 'Fungal infection status in nail clippings measured by culture after laser treatment.', 'timeFrame': 'Approximately 10 minutes after treatment', 'description': 'The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture after therapy.'}, {'measure': 'Fungal infection status in nail clippings measured by microscopy before laser treatment.', 'timeFrame': 'Approximately 10 minutes before treatment', 'description': 'The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy before therapy.'}, {'measure': 'Fungal infection status in nail clippings measured by culture before laser treatment.', 'timeFrame': 'Approximately 10 minutes before treatment', 'description': 'The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture before therapy.'}], 'secondaryOutcomes': [{'measure': 'Fungal infection status in nail clippings measured by PCR before laser treatment.', 'timeFrame': 'Approximately 10 minutes before treatment', 'description': 'The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR before therapy.'}, {'measure': 'Fungal infection status in nail clippings measured by PCR after laser treatment.', 'timeFrame': 'Approximately 10 minutes after treatment', 'description': 'The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR after therapy.'}, {'measure': 'Nail clippings temperatures', 'timeFrame': 'Approximately 2 seconds after end of treatment.', 'description': 'Nail clippings temperature measured at the end of treatment'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Onychomycosis of Toenail']}, 'descriptionModule': {'briefSummary': 'This study aims to assess if laser treatment can cure fungal infection in toenails.\n\nNail clippings from eligible subjects were obtained and randomised into two groups. All nail clippings were treated once with a 1064 nm Nd:YAG-laser. Before and after treatment, nail clippings were tested for fungal infection by microscopy and by culture.', 'detailedDescription': 'This study was carried out as a randomised controlled trial (RCT) including two treatment groups subjected to two different laser treatments. A 1064 nm Nd:YAG-laser (Candela Medical, Ellipse Nordlys (Nd:YAG 1064), USA) was used for all treatments.\n\nPotential subjects were recruited from general practitioners and skin clinics in North Jutland from August 24th, 2021, through December 2021.\n\nAll interventions and mycological tests for each subject were performed over the course of one day.\n\nAfter subjects were included, toenails with a clinical suspicion of onychomycosis (OM) were tested for fungal infection by culture and microscopy. At the same time, nail clippings from said toenails were obtained and randomised into one of two treatment groups, i.e., group A and group B.\n\nThe nail clippings were then treated with a 1064 nm Nd:YAG-laser with laser settings as specified by the treatment groups. All nail clippings were treated only once.\n\nImmediately after treatment, nail clippings were again tested for fungal infection by culture and microscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (\\>18 years)\n* Clinical suspicion of fungal infection in at least one toenail\n* Signed informed consent\n* Sufficient nail material to perform two cultures and one nail clipping\n\nExclusion Criteria:\n\n* Administration of oral antifungal medication in the last 12 months or topical antifungal medication in the last month\n* Diabetes mellitus with associated peripheral artery disease (PAD) or neuropathy\n* Under the influence of alcohol or illegal narcotics\n* Unable to understand written and spoken Danish'}, 'identificationModule': {'nctId': 'NCT05260450', 'briefTitle': 'Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser', 'orgStudyIdInfo': {'id': '20210020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Long-pulsed group)', 'description': 'Nail clippings allocated to group A received laser treatment with a 1064 nm Nd:YAG-laser. They received one treatment with laser settings: pulse duration 10 ms, spot size 3 mm, fluence 40-50 J/cm2, number of laser pulses 100 /cm2.', 'interventionNames': ['Device: 1064 nm Nd:YAG-laser therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (Short-pulsed group)', 'description': 'Nail clippings allocated to group B received laser treatment with a 1064 nm Nd:YAG-laser. They received one treatment with laser settings: pulse duration 0.3 ms, spot size 3 mm, fluence 40 J/cm2, number of laser pulses 100 /cm2.', 'interventionNames': ['Device: 1064 nm Nd:YAG-laser therapy']}], 'interventions': [{'name': '1064 nm Nd:YAG-laser therapy', 'type': 'DEVICE', 'description': 'All interventions and mycological tests for each subject were performed over the course of one day.\n\nAfter subjects were included, toenails with a clinical suspicion of OM were tested for fungal infection by culture and microscopy. At the same time, nail clippings from said toenails were obtained and randomised into one of two treatment groups, i.e., group A and group B.\n\nThe nail clippings were then treated with a 1064 nm Nd:YAG-laser with laser settings as specified by the treatment groups. All nail clippings were treated only once.\n\nImmediately after treatment, nail clippings were again tested for fungal infection by culture and microscopy.', 'armGroupLabels': ['Group A (Long-pulsed group)', 'Group B (Short-pulsed group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'North Denmark', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christian Bisp Sørensen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}