Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-03-08 @ 6:02 AM
Study NCT ID:
NCT02431104
Status:
WITHDRAWN
Last Update Posted:
2023-01-27
First Post:
2015-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor terminated study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2016-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-25', 'studyFirstSubmitDate': '2015-04-27', 'studyFirstSubmitQcDate': '2015-04-27', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Physician's Global Assessment of improvement post-final treatment", 'timeFrame': '3 months', 'description': 'Assessment of tattoo clearance by independent blinded reviewers'}], 'secondaryOutcomes': [{'measure': "Subject's Global Assessment of improvement post-final treatment", 'timeFrame': '3 months', 'description': 'Assessment of tattoo clearance by subject'}, {'measure': 'Subject Satisfaction post-final treatment', 'timeFrame': '3 months', 'description': 'Assessment of subject satisfaction with treatment results.'}, {'measure': 'Incidence and severity of adverse device effects', 'timeFrame': 'Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks', 'description': 'Assessment of ADEs immediately following each laser treatment and at the final follow-up visit.'}]}, 'conditionsModule': {'conditions': ['Laser Tattoo Removal']}, 'descriptionModule': {'briefSummary': 'A single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.', 'detailedDescription': 'This is a single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink. Subjects will receive up to 5 laser treatments, spaced 4 to 6 weeks apart, and will be followed at 3 months post-final treatment. Number of laser treatments required shall be based upon tattoo response to laser irradiation. The Investigator will terminate laser treatments upon 100% clearance of tattoo or after 5 treatment sessions, or in the event of an adverse effect which requires cessation of laser treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Fitzpatrick Skin Type I - VI\n* Target tattoo contains only black ink, is more than 1 year old and must have been obtained from a professional tattoo parlor.\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\nExclusion Criteria:\n\n* Target tattoo is 'home made' OR was obtained from an amateur artist.\n* Presence of double tattoo in the treatment area or presence of tribal, scarred, high-ink density, or highly colorful single tattoo.\n* Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.\n* History of allergic reaction to pigments following tattooing.\n* History of allergy to local anesthetics.\n* History of malignant tumors in the target area.\n* History of keloid scarring, hypertrophic scarring or of abnormal wound healing.\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."}, 'identificationModule': {'nctId': 'NCT02431104', 'briefTitle': 'Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cutera Inc.'}, 'officialTitle': 'Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser"', 'orgStudyIdInfo': {'id': 'C-15-EN02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser Treatment', 'description': 'Treatment to unwanted tattoo using a 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser', 'interventionNames': ['Device: 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser']}], 'interventions': [{'name': '532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser', 'type': 'DEVICE', 'otherNames': ['Enlighten laser'], 'description': 'Cutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser', 'armGroupLabels': ['Laser Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L6J 7W5', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'ICLS Dermatology and Plastic Surgery', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}], 'overallOfficials': [{'name': 'Sheetal Sapra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICLS Dermatology and Plastic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cutera Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}