Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-02 @ 1:31 PM
Study NCT ID:
NCT05363969
Status:
UNKNOWN
Last Update Posted:
2022-05-06
First Post:
2022-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Self Harm Scars With Fraxel Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical improvement of scars', 'timeFrame': '6 months', 'description': 'Patients will be assessed with pre and post treatment photography. Photographs will be taken at baseline and 1 month after the final treatment. After the final treatment both the investigator and patients will rate appearance of scarring as "worsened", "unchanged" or "improved" as compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Self Harm']}, 'descriptionModule': {'briefSummary': 'Treatment of self harm scars with fractionated laser.', 'detailedDescription': 'Fractionated resurfacing lasers have been shown to be useful for scars including acne scars, burns scars and striae. We will treat self harm scars with 3 to 4 treatments using a "Fraxel" fractionated laser. Patients will be screened to ensure they are not actively engaged in self harm behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self harm scars\n\nExclusion Criteria:\n\n* Active self harm behaviors'}, 'identificationModule': {'nctId': 'NCT05363969', 'briefTitle': 'Treatment of Self Harm Scars With Fraxel Laser', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Treatment of Self Harm Scars With Fraxel Laser', 'orgStudyIdInfo': {'id': 'IRB-21-06-3672'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fractionated laser resurfacing', 'type': 'DEVICE', 'otherNames': ['Fraxel'], 'description': 'Patients will receive 3-4 treatments with fractionated laser resurfacing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Darius Mehregan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chairman Dept of Dermatology', 'investigatorFullName': 'Darius Mehregan', 'investigatorAffiliation': 'Wayne State University'}}}}