Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 3:18 AM
Study NCT ID:
NCT01973166
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2013-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mdoucette@cutera.com', 'phone': '415-657-5518', 'title': 'Margot Doucette', 'organization': 'Cutera'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Picosecond Q-Switched Laser Treatment', 'description': 'Picosecond Q-Switched Laser Treatment (532 nm and 1064 nm)', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 42, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nanosecond Q-Switched Laser Treatment', 'description': 'Nanosecond Q-Switched Laser Treatment (532 nm and 1064 nm)', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 42, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pinpoint Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Picosecond Q-switched Laser Treatment', 'description': 'Picosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser\n\nPicosecond Q-switched Laser Treatment'}, {'id': 'OG001', 'title': 'Nanosecond Q-switched Laser Treatment', 'description': 'Nanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser\n\nNanosecond Q-switched Laser Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '2.54', 'groupId': 'OG000', 'lowerLimit': '2.13', 'upperLimit': '2.94'}, {'value': '2.17', 'groupId': 'OG001', 'lowerLimit': '1.77', 'upperLimit': '2.57'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-weeks post-final treatment', 'description': "Physician's Global Assessment Scale: 0 (min) - 4 (max) Higher scores represent better tattoo clearing 4 = Very Significant Clearing (\\> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%)\n\n1 = Mild Clearing (5 - 25%) 0 = No Change (\\< 5%)", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Picosecond Q-switched Laser Treatment', 'description': 'Picosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser\n\nPicosecond Q-switched Laser Treatment'}, {'id': 'OG001', 'title': 'Nanosecond Q-switched Laser Treatment', 'description': 'Nanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser\n\nNanosecond Q-switched Laser Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '9'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During treatment, approximately 10 minutes', 'description': 'Numeric Pain Rating Scale (Min=0; Max=10) Higher scores mean worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Subject tattoos were divided into 2 portions for assignment into 2 treatment arms: active control arm and treatment arm. One tattoo portion was treated with the Cutera Investigational picosecond Q-Switched Nd:YAG laser and the other tattoo portion with a comparator nanosecond Q-switched Nd:YAG laser'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '84', 'numSubjects': '42'}]}, {'type': 'Treatment With Cutera Investigational Picosecond Q-Switched Nd:YAG Laser', 'achievements': [{'groupId': 'FG000', 'numUnits': '42', 'numSubjects': '42'}]}, {'type': 'Treatment With Comparator Nanosecond Q-switched Nd:YAG Laser', 'achievements': [{'groupId': 'FG000', 'numUnits': '42', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '82', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'halves of tattoo'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Picosecond and Nanosecond Q-Switched Laser Treatment', 'description': 'Picosecond and Nanosecond Q-Switched Laser Treatment (532 nm and 1064 nm)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '51'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2013-10-25', 'resultsFirstSubmitDate': '2022-09-28', 'studyFirstSubmitQcDate': '2013-10-30', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-26', 'studyFirstPostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers.', 'timeFrame': '6-weeks post-final treatment', 'description': "Physician's Global Assessment Scale: 0 (min) - 4 (max) Higher scores represent better tattoo clearing 4 = Very Significant Clearing (\\> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%)\n\n1 = Mild Clearing (5 - 25%) 0 = No Change (\\< 5%)"}], 'secondaryOutcomes': [{'measure': 'Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment', 'timeFrame': 'During treatment, approximately 10 minutes', 'description': 'Numeric Pain Rating Scale (Min=0; Max=10) Higher scores mean worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tattoo Removal', 'Q-switched laser', 'Nd:YAG laser', 'Nanosecond laser', 'Picosecond laser', 'Laser therapy', 'Tattoo', 'pulsed-laser', 'laser treatment', 'remove tattoo', 'tattoo clearing', 'tattoo lightening', 'tattoo lighten'], 'conditions': ['Tattoo Removal']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the investigational medical grade laser device to a marketed medical grade laser device for effectiveness in lightening or clearing unwanted tattoos. This study will also compare any side effects from treatment with the devices.', 'detailedDescription': 'This is a two center study to evaluate the Cutera RF system. Subjects will be treated on the abdomen and / or flanks areas and / or saddle bag (upper lateral thigh, lateral hip and lower buttocks).\n\nThe objective of this study is to evaluate the thermal and histological changes observed in the subcutaneous tissue following RF exposure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females or Males, 18 to 65 years of age (inclusive)\n* Fitzpatrick Skin Type I - IV (Appendix 3)\n* Tattoos containing black/blue ink alone or in combination with other colors\n* Target tattoos older than 1 year\n* Presence of tattoos equal or greater than 2 square inches, not to exceed 12 square inches\n* Must be able to read, understand and sign the Informed Consent Form\n* Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions\n* Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and/or every day for the duration of the study, including the follow-up period\n* Willing to use hydroquinone approximately 4 weeks pre-treatment and post- treatment if required\n* Willingness to have digital photographs taken of the treated area\n* Agree not to undergo any other procedure(s) for the tattoo removal during the study\n* Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study\n\nExclusion Criteria:\n\n* Participation in a study of another device or drug within 6 months prior to enrollment or during the study\n* Prior treatment for tattoo removal in the target area, e.g., with q-switched laser, IPL, dermabrasion, electrocautery, cryotherapy\n* History of allergic reaction to pigments following tattooing\n* Presence of double tattoo in the treatment area\n* History of allergy to local anesthetics\n* History of allergy to topical antibiotics\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* Pregnant and/or breastfeeding\n* Having an infection, dermatitis or a rash in the treatment area\n* Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension\n* Suffering from coagulation disorders or taking prescription anticoagulation medications\n* History of keloid scarring, hypertrophic scarring or of abnormal wound healing\n* History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications\n* History of vitiligo, eczema, or psoriasis\n* History of connective tissue disease, such as systemic lupus erythematosus or scleroderma\n* History of seizure disorders due to light\n* Any use of medication that is known to increase sensitivity to light, such as tetracycline\n* History of herpes simplex and/or herpes zoster (shingles)\n* History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer\n* History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation\n* Systemic use of corticosteroid within 12 months of study participation\n* Use of oral isotretinoin within 12 months of study participation and topical use of isotretinoin within 6 months on the treated area\n* Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus\n* Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study\n* Current smoker or history of smoking within 6 months of study participation\n* As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study"}, 'identificationModule': {'nctId': 'NCT01973166', 'briefTitle': 'Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cutera Inc.'}, 'officialTitle': 'Randomized, Split-tattoo Study Comparing Safety and Efficacy of Picosecond and Nanosecond Q-switched Nd:YAG Lasers for Tattoo Removal', 'orgStudyIdInfo': {'id': 'C-13-TPS04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Picosecond Q-switched Laser Treatment', 'description': 'Picosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser', 'interventionNames': ['Device: Picosecond Q-switched Laser Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nanosecond Q-switched Laser Treatment', 'description': 'Nanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser', 'interventionNames': ['Device: Nanosecond Q-switched Laser Treatment']}], 'interventions': [{'name': 'Picosecond Q-switched Laser Treatment', 'type': 'DEVICE', 'armGroupLabels': ['Picosecond Q-switched Laser Treatment']}, {'name': 'Nanosecond Q-switched Laser Treatment', 'type': 'DEVICE', 'armGroupLabels': ['Nanosecond Q-switched Laser Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94005', 'city': 'Brisbane', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.68077, 'lon': -122.39997}}], 'overallOfficials': [{'name': 'David Apfelberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cutera Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}