Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT01491620
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2011-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D013684', 'term': 'Telangiectasis'}, {'id': 'D010787', 'term': 'Photosensitivity Disorders'}, {'id': 'D004890', 'term': 'Erythema'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D017496', 'term': 'Hypopigmentation'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, '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': {'eventGroups': [{'id': 'EG000', 'title': '532 nm KTP Laser Treatment', 'description': '532 nm KTP laser: Laser treatment sessions to neck or chest', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severity Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '532 nm KTP Laser Treatment', 'description': '532 nm KTP laser: Laser treatment sessions to neck and/or chest.'}], 'classes': [{'title': 'Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Upper Chest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': "Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists.\n\nBlinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 5 subjects were treated and then assessed at 24 weeks in their upper chest area'}, {'type': 'PRIMARY', 'title': "Physician's Global Assessment (Blinded)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '532 nm KTP Laser Treatment', 'description': '532 nm KTP laser: Laser treatment sessions to neck and/or chest.'}], 'classes': [{'title': 'Neck Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '.06', 'spread': '.97', 'groupId': 'OG000'}]}]}, {'title': 'Upper Chest Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': "Before and after subject photographs were presented to a panel of independent dermatologists. The panel was blinded to treatment parameters and the photograph time points. Each dermatologist was asked to select the baseline photograph and then rate improvement in Poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale.\n\nPhysician's Global Assessment (min= -1; max=4) Higher scores mean better outcome", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 5 subjects were treated and then assessed at 24 weeks in their upper chest area'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '532 nm KTP Laser Treatment', 'description': '532 nm KTP laser: Laser treatment sessions to neck and/or chest.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '532 nm KTP Laser Treatment', 'description': '532 nm KTP laser: Two laser treatment sessions to neck and/or chest. 6 weeks apart.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '64'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2011-12-05', 'resultsFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2011-12-13', 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-03', 'studyFirstPostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity Assessment Score', 'timeFrame': '24 weeks', 'description': "Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists.\n\nBlinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values"}, {'measure': "Physician's Global Assessment (Blinded)", 'timeFrame': '24 weeks', 'description': "Before and after subject photographs were presented to a panel of independent dermatologists. The panel was blinded to treatment parameters and the photograph time points. Each dermatologist was asked to select the baseline photograph and then rate improvement in Poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale.\n\nPhysician's Global Assessment (min= -1; max=4) Higher scores mean better outcome"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['poikiloderma of Civatte', 'red dyschromia', 'brown dyschromia', 'sun damage', 'neck', 'chest', 'dyschromia', 'pigmentation disorders', 'erythema', 'photosensitivity disorders', 'sun exposure', 'telangiectasia', 'hyperpigmentation', 'hypopigmentation'], 'conditions': ['Poikiloderma of Civatte', 'Dyschromia', 'Pigmentation Disorders', 'Telangiectasia', 'Photosensitivity Disorders']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Fitzpatrick Skin Type I - III\n* Clinical diagnosis of poikiloderma of Civatte affecting the neck and/or chest\n* Willing to refrain from using topical corticosteroids, retinoids and bleaching agents on the treated area\n* Agree not to undergo any other procedure for the treatment of poikiloderma of Civatte during the study\n* Willing and able to read, understand and sign the Informed Consent Form\n* Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions\n\nExclusion Criteria:\n\n* Any laser treatment on neck and/or chest within 12 months\n* Any topical treatment on neck and/or chest within 6 months\n* Pregnant and/or breastfeeding\n* Infection, dermatitis or a rash in the treatment area\n* Suffering from significant concurrent illness, such as Diabetes Mellitus or pertinent neurological disorders\n* History of seizure disorders due to light, fibromyalgia, connective tissue disease, vitiligo, psoriasis, pigmentary disorders, keloid scarring, hypertrophic scarring or abnormal wound healing\n* History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications\n* Having a known anticoagulative condition or taking anticoagulation medications\n* History of diseases stimulated by heat, unless treatment is conducted following a prophylactic regimen\n* Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely)\n* History of radiation to the head, neck and/or upper chest\n* Undergoing systemic chemotherapy for the treatment of cancer\n* Systemic use of isotretinoin (Accutane®) within 6 months\n* Any use of gold therapy\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 12 months of study\n* Participation in a study of another device or drug within 6 months\n* As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in study"}, 'identificationModule': {'nctId': 'NCT01491620', 'briefTitle': 'Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cutera Inc.'}, 'officialTitle': 'A Single-Center Prospective, Open-Label Study of the Excel V 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte', 'orgStudyIdInfo': {'id': 'C-11-XPC01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '532 nm KTP laser treatment', 'interventionNames': ['Device: 532 nm KTP laser']}], 'interventions': [{'name': '532 nm KTP laser', 'type': 'DEVICE', 'otherNames': ['Excel V'], 'description': 'Laser treatment sessions on the neck and/or chest', 'armGroupLabels': ['532 nm KTP laser treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55424', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Zel Skin and Laser Specialists', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cutera Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}