Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-31 @ 9:56 AM
Study NCT ID:
NCT05166395
Status:
WITHDRAWN
Last Update Posted:
2024-02-20
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Treated Scars and Optical Coherence Tomography (OCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'device not available to initiate study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POSAS Scar Assessment', 'timeFrame': 'Up to 13 weeks', 'description': 'Patient and Observer Scar Assessment Scale (POSAS) has a total score ranging from 6 (normal skin) to 60 (severely scarred skin).'}, {'measure': 'Surgical Scar Blood Flow', 'timeFrame': 'Up to 13 weeks', 'description': 'As measured using optical coherence tomography'}, {'measure': 'Surgical Scar Skin Roughness', 'timeFrame': 'Up to 13 weeks', 'description': 'As measured using optical coherence tomography'}, {'measure': 'Surgical Scar Collagen Content', 'timeFrame': 'Up to 13 weeks', 'description': 'As measured using optical coherence tomography'}, {'measure': 'Surgical Scar Epidermal Thickness', 'timeFrame': 'Up to 13 weeks', 'description': 'As measured using optical coherence tomography'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'Up to 13 weeks', 'description': 'Adverse events reported by participant and evaluated by treating physician'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['surgical scar'], 'conditions': ['Scar']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to learn about the effects of the 2940 nm Erbium: Yttrium-Aluminum-Garnet (Er:YAG) laser on treating surgical scar using optical coherence tomography, a medical imaging device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults age 18 years or older\n2. Patients should have Fitzpatrick skin types of I-IV\n3. Patients should have mild to severe post-surgical scarring located on head and neck\n4. Scar lengths of at least 3 cm.\n5. Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n1. The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study\n2. Scar size less than 3 cm in length\n3. Pregnant or lactating females\n4. Fitzpatrick skin type of V-VI\n5. Scleroderma\n6. Photosensitivity\n7. Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT05166395', 'briefTitle': 'Laser Treated Scars and Optical Coherence Tomography (OCT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Treatment of Surgical Scar With 2940 nm Erbium: Yttrium Aluminum Garnet (YAG) Laser Examined Under Optical Coherence Tomography', 'orgStudyIdInfo': {'id': '20190751'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Er:YAG laser Group', 'description': 'The study is a split-scar model. Participants will have half of their lesion receive a total of three sessions using 2940 nm Er:YAG laser spaced over a 4-week study participation interval.', 'interventionNames': ['Device: Er:YAG laser']}, {'type': 'NO_INTERVENTION', 'label': 'Control (No Intervention) Group', 'description': 'The study is a split-scar model. Participants will serve as their own control and have half of their lesion receive no intervention.'}], 'interventions': [{'name': 'Er:YAG laser', 'type': 'DEVICE', 'description': "2940 nm Er:YAG laser treatment spread over 3 sessions within 4 weeks on participant's scar on either the head/neck, trunk or extremities.", 'armGroupLabels': ['Er:YAG laser Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Keyvan Nouri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Keyvan Nouri', 'investigatorAffiliation': 'University of Miami'}}}}