Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-19 @ 9:28 PM
Study NCT ID:
NCT01282866
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2011-01-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Study@skinlasers.com', 'phone': '916-456-0400', 'title': 'Suzanne Kilmer, MD', 'organization': 'Laser & Skin Surgery Medical Group Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'HS Treatment', 'description': 'Treatment with the LightSheer Duet laser HS handpiece:\n\nTreatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.\n\nAll patients were treated in the Axilla area.', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'injured ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hair Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HS Treatment', 'description': 'Treatment with the LightSheer Duet laser HS handpiece:\n\nTreatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.\n\nAll patients were treated in the Axilla area.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '24', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 month following last treatment', 'description': 'The hair at the treatment area is counted at Baseline and 6 months following the last treatment.\n\nHair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline.', 'unitOfMeasure': 'percentage of hair clearance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HS Treatment', 'description': 'Treatment with the LightSheer Duet laser HS handpiece:\n\nTreatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.\n\nAll patients were treated in the Axilla area.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Each treatment', 'description': 'The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Level of Comfort Associated With Treatment', 'timeFrame': 'Each treatment', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Hair Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HS Treatment', 'description': 'Treatment with the LightSheer Duet laser HS handpiece:\n\nTreatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.\n\nAll patients were treated in the Axilla area.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 month following last treatment', 'description': 'The hair at the treatment area is counted at Baseline and 15 months following the last treatment.\n\nHair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline.', 'unitOfMeasure': 'percentage of hair clearance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants who completed 15 months follow up was 23 out of 35.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HS Treatment', 'description': 'Treatment with the LightSheer Duet laser HS handpiece:\n\nTreatment parameters: Fluence: 9-12J/cm\\^2, pulse duration: 30 to 70ms,medium to low vacuum levels.\n\nAll patients were treated in the Axilla area.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HS Treatment', 'description': 'Treatment with the LightSheer Duet laser HS handpiece:\n\nTreatment parameters: Fluence: 9-12J/cm\\^2, pulse duration: 30 to 70ms,medium to low vacuum levels.\n\nAll patients were treated in the Axilla area.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The power calculation proposed a sample of 35 participants to be sufficient to obtain qualitative assessment of hair removal, as well as the qualitative assessment of treatment time and pain experienced during treatment with the LightSheer Duet HS handpiece.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2011-01-09', 'resultsFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2011-01-23', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-20', 'studyFirstPostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hair Count', 'timeFrame': '6 month following last treatment', 'description': 'The hair at the treatment area is counted at Baseline and 6 months following the last treatment.\n\nHair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline.'}], 'secondaryOutcomes': [{'measure': 'Treatment Time', 'timeFrame': 'Each treatment', 'description': 'The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants.'}, {'measure': 'Level of Comfort Associated With Treatment', 'timeFrame': 'Each treatment'}, {'measure': 'Hair Count', 'timeFrame': '15 month following last treatment', 'description': 'The hair at the treatment area is counted at Baseline and 15 months following the last treatment.\n\nHair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline.'}]}, 'conditionsModule': {'conditions': ['Hair Removal']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to verify hair count reduction, associated comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed (HS) handpieces for temporary hair removal and permanent hair reduction. It is anticipated that the larger treatment size of the HS handpiece will result in faster treatment of larger areas; and that the lower energy levels will result in greater comfort.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy adult, female, 18 years of age or older with skin type I-IV;\n2. Having at least one suitable treatment area for hair removal with brown hair;\n3. Able and willing to comply with the treatment/follow-up schedule and requirements;\n4. Able to read, understand and provide written Informed Consent.\n5. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to market preference test enrollment and throughout the course of the study treatment.\n\nExclusion Criteria:\n\n1. Showing symptoms of hormonal disorders, as per the Investigator's discretion;\n2. Use of oral isotretinoin (Accutane®) within 6 months\n3. Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;\n4. History of keloid formation or poor wound healing in a previously injured skin area;\n5. Significant skin conditions affecting treated area or inflammatory skin conditions;\n6. Open laceration, abrasion, active cold sores or herpes sores on area to be treated;\n7. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;\n8. Having a history of bleeding disorder or taking anticoagulation medications before the washout period, per the package insert, and at the physician's discretion;\n9. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the area to be treated, personal history of melanoma;\n10. Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;\n11. Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;\n12. Tattoos in the treatment areas;\n13. Dysplastic nevi in the treatment areas;\n14. Participation in a study of another device or drug within 3 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria;\n15. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;\n16. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study;\n17. Allergy or history of an allergy to any topical anesthetic used;\n18. Pregnant, expectation of pregnancy, postpartum (\\<3 months) or nursing (\\<6 weeks);\n19. History of livedo reticularis, an autoimmune vascular disease;\n20. Hypersensitivity at the treatment site to any agents, solutions, or gel used in the treatment (applies to ET handpiece only), if no alternative exists;"}, 'identificationModule': {'nctId': 'NCT01282866', 'briefTitle': 'Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumenis Be Ltd.'}, 'officialTitle': 'Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece', 'orgStudyIdInfo': {'id': 'LUM- ABU-LSDuet-08-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HS treatment', 'description': 'Treatment with HS handpiece', 'interventionNames': ['Device: LightSheer Duet']}], 'interventions': [{'name': 'LightSheer Duet', 'type': 'DEVICE', 'description': 'LightSheer Duet HS handpiece', 'armGroupLabels': ['HS treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Laser & Skin Surgery Medical Group Inc', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lumenis Be Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}