Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-05 @ 6:27 PM
Study NCT ID:
NCT03333759
Status:
WITHDRAWN
Last Update Posted:
2018-07-26
First Post:
2017-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Acne Scars With Erbium:Yttrium Aluminum Garnet (Er:YAG) Laser Examined Under OCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Difficult recruiting participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2017-08-01', 'studyFirstSubmitQcDate': '2017-11-03', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood flow', 'timeFrame': 'During 8 weeks', 'description': 'Optical coherence tomography (OCT) will be used to quantitatively measure changes in facial atrophic acne scars in terms of blood flow (proportion of signals with strong dynamic signal (%)/depth (mm)).'}, {'measure': 'Change in epidermal thickness', 'timeFrame': 'During 8 weeks', 'description': 'Optical coherence tomography (OCT) will be used to quantitatively measure changes in facial atrophic acne scars in terms of epidermal thickness (mm).'}, {'measure': 'Change in collagen content', 'timeFrame': 'During 8 weeks', 'description': 'OCT will be used to qualitatively measure changes in facial atrophic acne scars in terms of collagen content. Collagen content will be measured in terms of brightness of OCT scan. Areas of skin that contain collagen tend to be brighter (more white in color) whereas areas with less collagen content tend to be darker.'}, {'measure': 'Change in skin roughness', 'timeFrame': 'During 8 weeks', 'description': 'OCT will be used to quantitatively measure changes in facial atrophic acne scars in terms of skin roughness (µm).'}], 'secondaryOutcomes': [{'measure': 'The Patient Scar Assessment Scale', 'timeFrame': 'During 8 weeks', 'description': 'Scale (1-10) used to qualitatively monitor treatment and changes in scars by the patient.'}, {'measure': 'The Observer Scar Assessment Scale', 'timeFrame': 'During 8 weeks', 'description': 'Scale (1-10) used to qualitatively monitor treatment and changes in scars by the dermatologist.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['laser', 'Er:YAG laser', 'acne', 'acne vulgaris', 'optical coherence tomography'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This study is examining the effects of the 2940 nm Er:YAG on atrophic facial acne scars under optical coherence tomography in terms of blood flow, vessel shape, skin roughness, collagen content, and epidermal thickness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients should be 18-90 years of age\n2. Patients should have Fitzpatrick skin types of I-III\n3. Patients should have at least mild acne\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. Pregnant or lactating females\n3. Fitzpatrick skin type of IV-VI\n4. A history of keloids or hypertrophic scars\n5. Scleroderma\n6. Photosensitivity\n7. Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months\n8. Subjects with a known history of herpes simplex'}, 'identificationModule': {'nctId': 'NCT03333759', 'briefTitle': 'Treatment of Acne Scars With Erbium:Yttrium Aluminum Garnet (Er:YAG) Laser Examined Under OCT', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Treatment of Atrophic Facial Acne Scars With Er:YAG Laser Examined Under Optical Coherence Tomography', 'orgStudyIdInfo': {'id': '20170490'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser Treatment', 'description': 'Patients will receive one laser treatment (week 0) with the Erbium YAG laser at a 2940nm wavelength (Alma - Harmony XL Laser) and parameters corresponding with their acne scar severity. They will then return to the clinic 1, 4 and 8 weeks (7, 30, and 56 days + 7 days) after the treatment for their scars to be evaluated under optical coherence tomography.\n\nLaser parameters are as follows:\n\niPixelEr 2940nm Erbium:YAG Module: mild scars: 7 by 7 (7X7) mm tip, energy 1400-1600 millijoules/P (mJ), pulse energy 5 Hz, 2-6 stacks, pulse mode L, 2-3 passes, 10% overlap moderate scars: 7X7 mm tip, energy 1600-1800 mJ/P, pulse energy 5 Hz, 2-6 stacks, pulse mode L, 2-3 passes, 10% overlap severe scars: 7X7 mm tip, 1800-2000 mJ/P, pulse energy 5 Hz, 2-6 stacks, pulse mode L, 2-3 passes, 10% overlap', 'interventionNames': ['Device: Alma - Harmony XL Laser']}], 'interventions': [{'name': 'Alma - Harmony XL Laser', 'type': 'DEVICE', 'otherNames': ['Modified Alma Laser Harmony Neodymium-Doped Yttrium Aluminium Garnet (Nd:YAG) Module'], 'description': 'The Erbium YAG laser at a 2940nm wavelength is used for ablative laser resurfacing as well as treating acne scars.', 'armGroupLabels': ['Laser Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33130', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Keyvan Nouri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Medicine', 'investigatorFullName': 'Keyvan Nouri', 'investigatorAffiliation': 'University of Miami'}}}}