Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT02472405
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2015-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multiplex Laser vs. PDL (Pulsed Dye Laser ) in the Treatment of Surgical Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'KNouri@med.miami.edu', 'phone': '305-243-3380', 'title': 'Keyvan Nouri MD', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Seven weeks.', 'eventGroups': [{'id': 'EG000', 'title': '595nm PDL - 595/1064nm Multiplex Laser - Control', 'description': "A third of each participant's scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). The remaining third of the scar was left untreated for the duration of the study. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.\n\n595/1064nm Multiplex Laser: The multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL.", 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 2, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Minor bleeding and scabbing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'POSAS (The Patient and Observer Scar Assessment Scale) Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '595nm PDL', 'description': 'One third of the scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.\n\n595nm PDL: One third of the scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week).'}, {'id': 'OG001', 'title': '595/1064nm Multiplex Laser', 'description': 'One third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.\n\n595/1064nm Multiplex Laser: The multiplex cynergy laser was used for this study. A third of the scar was solely be treated with the 595nm PDL.'}, {'id': 'OG002', 'title': 'Control', 'description': 'One third of the scar was left untreated for the duration of the study. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '1.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 months', 'description': 'POSAS is a scale that contains the following parameters: pigmentation, vascularity, pliability, height, surface area, and patient input with regards to pain, itching, relief, stiffness, color and thickness. Both the patient and the observer are asked to give their Overall Opinion on the appearance of the scar. Again, a 10-point scale (ranging from 1 to 10) is used in which 10 corresponds to the worst imaginable scar.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The measurement used for this outcome was completed 4 weeks post final intervention, only eight participants completed the study protocol, but only 6 participant's POSAS score was collected. Observer's score for the POSAS is not available. Only the score for the participants was reported."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '595nm PDL - 595/1064nm Multiplex - Control', 'description': "A third of each participant's scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). And the remaining third of the scar was left untreated for the duration of the study. The order of treatment was not randomized. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '595nm PDL - 595/1064nm Multiplex - Control', 'description': "A third of each participant's scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). And the remaining third of the scar was left untreated for the duration of the study. The order of treatment was not randomized. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each participant scar was randomized to the 3 treatment arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2015-03-02', 'resultsFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-24', 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POSAS (The Patient and Observer Scar Assessment Scale) Measure', 'timeFrame': '2 months', 'description': 'POSAS is a scale that contains the following parameters: pigmentation, vascularity, pliability, height, surface area, and patient input with regards to pain, itching, relief, stiffness, color and thickness. Both the patient and the observer are asked to give their Overall Opinion on the appearance of the scar. Again, a 10-point scale (ranging from 1 to 10) is used in which 10 corresponds to the worst imaginable scar.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Scar']}, 'descriptionModule': {'briefSummary': 'This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.', 'detailedDescription': 'This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.\n\nPatients will be offered the opportunity of enrolling in the trial before their surgery. If they qualify and agree to participate they will sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) form.\n\nThe surgical defect should be closed primarily, with the minimal scar length being 3cm. The scar will be randomized into 3 equal thirds, each third will randomly receive either: no treatment, 595nm PDL, or 595/1064nm Multiplex laser. A total of 3 laser treatments will be performed over a period of 3 weeks (one treatment session performed every week), and the patient will come in for a final follow up visit, for a final assessment of the scar using the Patient and Observer Scar Assessment Scale (POSAS) system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fitzpatrick skin types 1-3\n* Suture line should be at least 3 cm long\n\nExclusion Criteria:\n\n* The patient should not be receiving any alternate systemic, topical or intralesional treatment of the scars during the study\n* Pregnant or lactating females\n* Fitzpatrick skin type 4-6\n* A history of keloids or hypertrophic scars'}, 'identificationModule': {'nctId': 'NCT02472405', 'briefTitle': 'Multiplex Laser vs. PDL (Pulsed Dye Laser ) in the Treatment of Surgical Scars', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Comparing the 595/1064nm Multiplex Laser to the 595nm PDL in the Treatment of Surgical Scars in a Blinded, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '20140348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '595nm PDL', 'description': 'One third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week). A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system.', 'interventionNames': ['Device: 595nm PDL']}, {'type': 'ACTIVE_COMPARATOR', 'label': '595/1064nm Multiplex Laser', 'description': 'One third of the scar will be treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system.', 'interventionNames': ['Device: 595/1064nm Multiplex Laser']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'One third of the scar will be left untreated for the duration of the study. A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system.'}], 'interventions': [{'name': '595/1064nm Multiplex Laser', 'type': 'DEVICE', 'description': 'The multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL.', 'armGroupLabels': ['595/1064nm Multiplex Laser']}, {'name': '595nm PDL', 'type': 'DEVICE', 'description': 'One third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week).', 'armGroupLabels': ['595nm PDL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Keyvan Nouri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami Sylvester Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Keyvan Nouri', 'investigatorAffiliation': 'University of Miami'}}}}