Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT02756806
Status:
TERMINATED
Last Update Posted:
2023-02-21
First Post:
2016-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Evaluation 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', 'description': 'Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Frosting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Degree of Tattoo Clearing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Picosecond Q-switched Laser', 'description': 'Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.\n\nPicosecond Q-switched laser: Each subject will receive up to 6 laser treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-weeks post-final treatment', 'description': "Degree of tattoo clearing at 12 weeks post-final treatment as assessed by independent blinded reviewers (Physician's Global Assessment of Improvement).\n\nMin=0; Max=4 Higher score indicate 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': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Picosecond Q-switched Laser', 'description': 'Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Study terminated early', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Picosecond Q-switched Laser', 'description': 'Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.\n\nPicosecond Q-switched laser: Each subject will receive up to 6 laser treatments.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '46'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Change protocol to include multiple sites.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2016-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2016-04-28', 'resultsFirstSubmitDate': '2018-03-12', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-26', 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of Tattoo Clearing', 'timeFrame': '12-weeks post-final treatment', 'description': "Degree of tattoo clearing at 12 weeks post-final treatment as assessed by independent blinded reviewers (Physician's Global Assessment of Improvement).\n\nMin=0; Max=4 Higher score indicate 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%)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tattoo removal, Picosecond Laser, Q-switched Laser'], 'conditions': ['Tattoo Removal']}, 'descriptionModule': {'briefSummary': 'Evaluate safety and efficacy with the enlighten laser for tattoo removal.', 'detailedDescription': 'The purpose of this investigation is to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser 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 (Appendix 3).\n* Target tattoo contains single or multi-color ink, which includes blue and/or green.\n* Target tattoos must be older than 1 year.\n* Target tattoo 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 within 6 months prior to enrollment or during the study.\n* Target tattoo contains only black ink.\n* Target tattoo is a double tattoo where a first tattoo was covered with a second tattoo.\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.\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 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': 'NCT02756806', 'briefTitle': 'A Clinical Evaluation for Tattoo Removal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cutera Inc.'}, 'officialTitle': 'A Clinical Evaluation of a Novel Multi-Wavelength Laser for Tattoo Removal', 'orgStudyIdInfo': {'id': 'C-16-EN11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Picosecond Q-switched Laser', 'description': 'Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.', 'interventionNames': ['Device: Picosecond Q-switched laser']}], 'interventions': [{'name': 'Picosecond Q-switched laser', 'type': 'DEVICE', 'otherNames': ['Enlighten'], 'description': 'Each subject will receive laser treatments with Enlighten laser', 'armGroupLabels': ['Picosecond Q-switched Laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94005', 'city': 'Brisbane', 'state': 'California', 'country': 'United States', 'facility': 'Cutera Research Center', 'geoPoint': {'lat': 37.68077, 'lon': -122.39997}}], 'overallOfficials': [{'name': 'Lourdes Moldre, NP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cutera Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cutera Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}