Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 9:51 PM
Study NCT ID:
NCT01057134
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2010-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ultrasound Device for Hair Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mdoucette@cutera.com', 'phone': '415-656-9612', 'title': 'Margot Doucette', 'organization': 'Cutera'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Study Participants', 'description': 'Subjects were treated on the calf, thigh, and arm with the Cutera UHAIR device.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blistering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction in Hair Count in the Treated Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arms'}, {'id': 'OG001', 'title': 'Calf'}, {'id': 'OG002', 'title': 'Thigh'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '18.7', 'spread': '15.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 3 months post final treatment (up to 28 weeks)', 'description': 'Percent hair reduction 3 months post final treatment compared to baseline in the treated areas', 'unitOfMeasure': 'percentage of hair reduction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Subjects were treated on the calf, thigh, and arm with the Cutera UHAIR device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2010-01-25', 'resultsFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2010-01-26', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-22', 'studyFirstPostDateStruct': {'date': '2010-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Hair Count in the Treated Area', 'timeFrame': 'baseline and 3 months post final treatment (up to 28 weeks)', 'description': 'Percent hair reduction 3 months post final treatment compared to baseline in the treated areas'}]}, 'oversightModule': {'oversightHasDmc': False, 'isUnapprovedDevice': True}, 'conditionsModule': {'keywords': ['Hair Reduction Arm Leg', 'Unwanted hair'], 'conditions': ['Hair Removal']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR ultrasound device for hair removal.', 'detailedDescription': "The purpose of this study is to evaluate the Cutera UHAIR device for safety and efficacy for removal and long term reduction of unwanted hair on subjects with Fitzpatrick skin types I-IV and dark (black or brown), red, and blonde colored hair.\n\nAt investigator's discretion, each subject will receive treatments and will be scheduled for follow-up visits after the final treatment. The treated area(s) will be photographed at each visit for analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female at least 18 years of age\n* Fitxpatrick skin type I-IV\n* Area with unwanted hair\n* Subject must be able to read, understand and sign the consent form\n* Subject must adhere to the follow-up schedule and study instruction\n\nExclusion Criteria:\n\n* Simultaneous participation in any other clinical study\n* Inability or unwillingness to follow the treatment schedule\n* Inability or unwillingness to sign the informed consent\n* Infection in the target area\n* Any disease or condition that could impair wound healing\n* History of keloid formation\n* History of malignant tumors in the target area\n* Skin abnormalities in the target area, e.g. cuts, scrapes, wounds, scars, large moles\n* History of hair removal in target area (light based or electrolysis)\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT01057134', 'briefTitle': 'Ultrasound Device for Hair Removal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cutera Inc.'}, 'officialTitle': 'Cutera UHAIR for Hair Removal', 'orgStudyIdInfo': {'id': 'C-09-UP01'}, 'secondaryIdInfos': [{'id': 'C-09-UP01', 'type': 'OTHER', 'domain': 'Cutera Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Site treated with UHAIR', 'description': 'The arm, calf, and thigh will be treated', 'interventionNames': ['Device: Cutera Ultrasound Device']}], 'interventions': [{'name': 'Cutera Ultrasound Device', 'type': 'DEVICE', 'otherNames': ['UHAIR'], 'description': 'Pulse duration 10-100 ms, fluence greater or equal to 50 J/cm2, contact tip temperature 5-30 celsus, frequency 5-20 MHz.', 'armGroupLabels': ['Site treated with UHAIR']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cutera Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}