Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT02755467
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2016-04-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the Treatment of Spider Angioma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053844', 'term': 'Lasers, Solid-State'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mdoucette@cutera.com', 'phone': '415-657-5518', 'title': 'Margot Doucette', 'organization': 'Cutera'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks post final laser treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Laser Treatment', 'description': 'Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).\n\nKTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 14, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Physician's Global Assessment Scale for Improvement of Spider Angioma", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).\n\nKTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Four weeks post laser treatment.', 'description': "Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale.\n\nHigh scores indicate better outcomes:\n\n0\\. None\n\n1. Mild\n2. Moderate\n3. Significant\n4. Very Significant\n5. Complete Removal", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject was lost to follow up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Laser Treatment', 'description': 'Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).\n\nKTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Laser Treatment', 'description': 'Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).\n\nKTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.7', 'spread': '19.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2016-04-25', 'resultsFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-27', 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Physician's Global Assessment Scale for Improvement of Spider Angioma", 'timeFrame': 'Four weeks post laser treatment.', 'description': "Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale.\n\nHigh scores indicate better outcomes:\n\n0\\. None\n\n1. Mild\n2. Moderate\n3. Significant\n4. Very Significant\n5. Complete Removal"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spider Angioma']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.', 'detailedDescription': 'The purpose of this study is to evaluate the safety and efficacy of the 532 nm KTP laser within the Cutera Excel V system for the treatment of spider angiomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females, 5 to 65 years of age (inclusive).\n2. Fitzpatrick Skin Types I-IV\n3. Subject must be able to read, understand and sign the Informed Consent Form.\n4. If subject is a minor (\\<18 years old in Illinois), Assent must be obtained from the subject and a Parental Consent Form must be signed by the parents or legal guardian.\n5. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.\n6. Willing to have limited sun exposure for the duration of the study, including the follow-up period.\n7. Willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes\n8. Agree not to undergo any other procedure for the treatment of spider angioma during the study.\n\nExclusion Criteria:\n\n1. Pregnant.\n2. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.\n3. Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin.\n4. History of seizure disorders due to light.\n5. Systemic use of isotretinoin (Accutane®) within 6 months of study participation.\n6. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.\n7. Participation in a study of another device or drug within 3 months prior to enrollment or during the study.\n8. In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study.'}, 'identificationModule': {'nctId': 'NCT02755467', 'briefTitle': 'Clinical Evaluation of the Treatment of Spider Angioma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cutera Inc.'}, 'officialTitle': 'A Clinical Evaluation of the Treatment of Spider Angioma Using a Dual Wavelength Laser Emitting 532 nm Laser Energy', 'orgStudyIdInfo': {'id': 'C-16-EV08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser treatment', 'description': 'Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).', 'interventionNames': ['Device: KTP laser']}], 'interventions': [{'name': 'KTP laser', 'type': 'DEVICE', 'otherNames': ['Cutera Excel V'], 'description': 'Dual Wavelength Laser Emitting 532 nm Laser Energy', 'armGroupLabels': ['Laser treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60563', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'DuPage Medical Group', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}], 'overallOfficials': [{'name': 'Kelly Stankiewicz, MD FAAD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DuPage Medical Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cutera Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}