Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-01-04 @ 5:03 PM
Study NCT ID:
NCT02110095
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2014-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamie.trimper@cynosure.com', 'phone': '800-886-2966', 'title': 'Jamie Trimper', 'organization': 'Cynosure'}, 'certainAgreement': {'otherDetails': 'The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the study duration, around 19 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Picosure Laser System', 'description': 'Picosure Laser System for the treatment of unwanted tattoos\n\nPicosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blistering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pinpoint Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Crusting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypopigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Tattoo Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Picosure Laser System', 'description': 'Picosure Laser System for the treatment of unwanted tattoos\n\nPicosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos'}], 'classes': [{'categories': [{'title': '# of Patients with 20% Improvement', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '# of Patients with 30% Improvement', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months post last treatment', 'description': 'Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physician Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Picosure Laser System', 'description': 'Picosure Laser System for the treatment of unwanted tattoos\n\nPicosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos'}], 'classes': [{'categories': [{'title': 'Patients scored a 5 by physician', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Patients scored a 4 by Physician', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months post last treatment', 'description': 'This measures the physician satisfaction from 1 to 5, where 5 is the most satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Picosure Laser System', 'description': 'Picosure Laser System for the treatment of unwanted tattoos\n\nPicosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Picosure Laser System', 'description': 'Picosure Laser System for the treatment of unwanted tattoos\n\nPicosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Indian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One of the subjects did not report his/her race/ethnicity.'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Fitzpatrick Skin Type I', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Fitzpatrick Skin Type II', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Fitzpatrick Skin Type III', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Fitzpatrick Skin Type IV', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Fitzpatrick Skin Type V', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Fitzpatrick Skin Type VI', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Fitzpatrick Skin Score is used to determine skin color. It is a numerical system that classifies skin into six types (Type I, Type II, Type III, Type IV, Type V and Type VI) based on the numerical score achieved (ranging from 0 to 36). The lower the score (and skin type number), the fairer the skin. The higher the score (and skin type number), the more deeply pigmented the skin is.\n\nThe scale comes from this source:\n\nGupta, Sharma. Skin typing: Fitzpatrick grading and others. Clinics in Dermatology. 2019;37(5):430-436. doi:10.1016/j.clindermatol.2019.07.010', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2014-04-08', 'resultsFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-17', 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Tattoo Clearance', 'timeFrame': '2 months post last treatment', 'description': 'Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo.'}], 'secondaryOutcomes': [{'measure': 'Physician Satisfaction Questionnaire', 'timeFrame': '2 months post last treatment', 'description': 'This measures the physician satisfaction from 1 to 5, where 5 is the most satisfied.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Unwanted Tattoos']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the Picosure Laser System for the treatment of unwanted tattoos.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Is a healthy male or female between 18 and 85 years old.\n2. Is willing to consent to participate in the study.\n3. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.\n4. The tattoo must include red pigment.\n\nExclusion Criteria:\n\n1. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.\n2. Is hypersensitive to light exposure OR takes photo sensitized medication.\n3. Has active or localized systemic infections.\n4. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).\n5. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.\n6. Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.\n7. Has used Accutane within 6 months prior to enrollment.\n8. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.\n9. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).\n10. Has a history of keloids.\n11. Has evidence of compromised wound healing.\n12. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.\n13. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.\n14. Is allergic to topical lidocaine or topical steroids."}, 'identificationModule': {'nctId': 'NCT02110095', 'briefTitle': 'Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cynosure, Inc.'}, 'officialTitle': 'Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos', 'orgStudyIdInfo': {'id': 'CYN14-PICO-MULTI-JD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Picosure Laser System', 'description': 'Picosure Laser System for the treatment of unwanted tattoos', 'interventionNames': ['Device: Picosure Laser System']}], 'interventions': [{'name': 'Picosure Laser System', 'type': 'DEVICE', 'description': 'Picosure Laser System for the Treatment of Unwanted Tattoos', 'armGroupLabels': ['Picosure Laser System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Skin Care Physicians', 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}], 'overallOfficials': [{'name': 'Patricia Krantz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cynosure, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cynosure, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}