Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-26 @ 7:24 PM
Study NCT ID:
NCT02935660
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2016-10-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-Wavelength Laser Tattoo Removal Pivotal Study
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': {'timeFrame': 'Adverse event data were collected 6 weeks post final laser treatment, up to an average of 7 months', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Treatment with investigational Cutera enlighten laser for tattoo removal\n\nenLighten Laser: Laser tattoo removal treatment', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Frosting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Crusting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tattoo Clearing as Rated by Blinded Evaluator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with investigational Cutera enlighten laser for tattoo removal\n\nenLighten Laser: Laser tattoo removal treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-final treatment, approximately 7 months after study start', 'description': 'Percentage of subjects with tattoo ink clearing of at least 50% or more at 6 weeks post-final treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Degree of Overall Tattoo Ink Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator (Physician's Global Assessment of Improvement).", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with investigational Cutera enlighten laser for tattoo removal\n\nenLighten Laser: Laser tattoo removal treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '3.43', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post-final treatment, approximately 7 months after study start', 'description': "Physician's Global Assessment of Improvement (min=0; max=4) Higher scores mean better outcomes", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction Levels at 6 Weeks Post-final Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with investigational Cutera enlighten laser for tattoo removal\n\nenLighten Laser: Laser tattoo removal treatment'}], 'classes': [{'title': 'number of subjects reporting they were "extremely satisfied" or "satisfied" with level of clearing', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'number of subjects reporting they were neutral with level of clearing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'number of subjects who said they would the investigational treatment again', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post-final treatment, approximately 7 months after study start', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Pain During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with investigational Cutera enlighten laser for tattoo removal\n\nenLighten Laser: Laser tattoo removal treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '2.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Reported by subject at the end of each treatment visit, up to 5 months', 'description': 'Numeric Pain Rating Scale (Min=0; Max=10) Higher scores indicate worse outcomes Pain values from all treatment visits and subjects were combined and averaged.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Treatment with investigational Cutera enlighten laser for tattoo removal'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Treatment with investigational Cutera enlighten laser for tattoo removal\n\nenLighten Laser: Laser tattoo removal treatment'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '61'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-02', 'size': 1244409, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-13T17:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2016-10-14', 'resultsFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-25', 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tattoo Clearing as Rated by Blinded Evaluator', 'timeFrame': '6 weeks post-final treatment, approximately 7 months after study start', 'description': 'Percentage of subjects with tattoo ink clearing of at least 50% or more at 6 weeks post-final treatment'}], 'secondaryOutcomes': [{'measure': "Degree of Overall Tattoo Ink Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator (Physician's Global Assessment of Improvement).", 'timeFrame': '6 weeks post-final treatment, approximately 7 months after study start', 'description': "Physician's Global Assessment of Improvement (min=0; max=4) Higher scores mean better outcomes"}, {'measure': 'Subject Satisfaction Levels at 6 Weeks Post-final Treatment', 'timeFrame': '6 weeks post-final treatment, approximately 7 months after study start'}, {'measure': 'Subject Pain During Treatment', 'timeFrame': 'Reported by subject at the end of each treatment visit, up to 5 months', 'description': 'Numeric Pain Rating Scale (Min=0; Max=10) Higher scores indicate worse outcomes Pain values from all treatment visits and subjects were combined and averaged.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tattoo Removal']}, 'descriptionModule': {'briefSummary': 'Multi-center study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal', 'detailedDescription': 'A multi-center prospective, open-label, uncontrolled pivotal study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female or Male, 18 to 65 years of age (inclusive).\n* Fitzpatrick Skin Type I - VI.\n* Target tattoo contains single or multi-color ink, and must include blue and/or green ink.\n* Target tattoos must be older than 1 year.\n* Target treatment area not to exceed 12 square inches.\n* Subject 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 have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.\n* Agree to not undergo any other procedure(s) for tattoo removal during the study (as applicable).\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, and no plans to become pregnant for the duration of the study.\n\nExclusion Criteria:\n\n* Participation in a clinical trial of a drug or another device in the target area during the study.\n* Target tattoo contains only black ink.\n* History of allergic reaction to pigments following tattooing.\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 per investigator's discretion.\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 according to Investigator's discretion.\n* History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.\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 or isotretinoin, as applicable, within 6 months of study participation.\n* Anytime in life, having 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': 'NCT02935660', 'briefTitle': 'Multi-Wavelength Laser Tattoo Removal Pivotal Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cutera Inc.'}, 'officialTitle': 'A Prospective, Multi-Center Pivotal Clinical Evaluation of a Novel Multi-Wavelength Laser for Tattoo Removal', 'orgStudyIdInfo': {'id': 'C-16-EN13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Treatment with investigational Cutera enlighten laser for tattoo removal', 'interventionNames': ['Device: enLighten Laser']}], 'interventions': [{'name': 'enLighten Laser', 'type': 'DEVICE', 'description': 'Laser tattoo removal treatment', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94005', 'city': 'Brisbane', 'state': 'California', 'country': 'United States', 'facility': 'Cutera Research Clinic', 'geoPoint': {'lat': 37.68077, 'lon': -122.39997}}, {'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Skin Care Physicians', 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cutera Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}