Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT01516034
Status:
TERMINATED
Last Update Posted:
2012-12-21
First Post:
2012-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy of the Cupola Ultrasonic Tattoo Removal Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drfriedmanlaser@gmail.com', 'phone': '+972-2-5635673', 'title': 'David J. Friedman, Principal Investigator', 'organization': 'Dr David Friedman Laser & Skin Center'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Cupola tattoo removal treatment', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild thickening of the skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tattoo Removal Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Cupola tattoo removal treatment'}], 'timeFrame': '6 months (termination)', 'description': 'Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit:\n\n1. Scoring by independent dermatologist\n2. Measuring pigment clearance using image analysis', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants that completed follow up.'}, {'type': 'SECONDARY', 'title': 'Tolerability Score', 'timeFrame': '0, 2, 4, 6, 8, 10 weeks (after every treatment)', 'description': 'The tolerability of the procedure will be scored by the subject using a Pain Visual Analog Scale on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Cupola tattoo removal treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Recruitment period: 20-Nov-2011 to 11-Mar-12 Location: Dermatological clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Cupola tattoo removal treatment'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '6.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Israel', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Sponsor decided that the results were not significant enough to continue.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-22', 'studyFirstSubmitDate': '2012-01-16', 'resultsFirstSubmitDate': '2012-11-09', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-22', 'studyFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tattoo Removal Efficiency', 'timeFrame': '6 months (termination)', 'description': 'Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit:\n\n1. Scoring by independent dermatologist\n2. Measuring pigment clearance using image analysis'}], 'secondaryOutcomes': [{'measure': 'Tolerability Score', 'timeFrame': '0, 2, 4, 6, 8, 10 weeks (after every treatment)', 'description': 'The tolerability of the procedure will be scored by the subject using a Pain Visual Analog Scale on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tattoo removal', 'ultrasound'], 'conditions': ['Tattooing']}, 'descriptionModule': {'briefSummary': 'The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.', 'detailedDescription': 'The Cupola system is a non-invasive device for pigment/tattoo removal based on ultrasound technology. The safety of the device was demonstrated in a previous pilot study approved by the Herzog Helsinki committee #167-09, Ministry of Health April 2010 #HT-5293) showing that no risk was associated with the procedure.\n\nThis study is designed to determine the efficacy of the device for tattoo removal in up to 6 treatments in different treatment intervals. Three areas of the tattoo that are similar in size, color, and intensity will be chosen. One area will not be treated; the second will receive 6 treatments in 2-3 week intervals; the third will receive 3 treatments in 4-6 week intervals. The evaluations will include color measurements, photography, subject comfort and skin condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Tattoos\n\n * Age of tattoo - more than 1 year since application\n * Type - decorative (not cosmetic)\n * Not previously treated\n2. General\n\n * At least 18 years of age\n * Agrees to sign the Informed Consent\n * Willingness to remove tattoo\n * Willingness to have photographs and color measurements of the treated area taken and to be used for marketing and educational presentation and/or publications\n * Willingness to follow the treatment schedule and post treatment care requirement for tattooing and removal\n * Not planning to remove the tattoo in a different procedure during the time of the experiment\n\nExclusion Criteria:\n\n1. Skin conditions\n\n * Skin type 5 and 6\n * History of keloid formation\n * Active herpes simplex\n * Psoriasis or vitiligo\n2. Other medical conditions\n\n * HIV or Hepatitis\n * Pregnancy or intention to become pregnant in the next 6 months\n * No allergic reaction during the tattooing process.\n3. Medication\n\n * Currently taking anticoagulant medication, blood thinners, steroids or immunosuppressive\n * Taking isotretinoin (Accutane) currently or within the last 6 months\n * Minocyclin'}, 'identificationModule': {'nctId': 'NCT01516034', 'briefTitle': 'The Efficacy of the Cupola Ultrasonic Tattoo Removal Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cupola Medical Ltd'}, 'officialTitle': 'The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design', 'orgStudyIdInfo': {'id': 'CTR-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Cupola Tattoo Removal Device', 'interventionNames': ['Device: Cupola Tattoo Removal device']}], 'interventions': [{'name': 'Cupola Tattoo Removal device', 'type': 'DEVICE', 'description': 'Up to 6 treatments with the device every 2-3 weeks to the tattoo area.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Dr David Friedman Laser & Skin Center, Diskin 60 st.', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'David J Friedman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedman Skin & Laser Center'}, {'name': 'Lilach Gavish, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Friedman Skin & Laser Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cupola Medical Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}