Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT07087405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Striae Distensae Treatment Using Deep Skin Abrasion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057896', 'term': 'Striae Distensae'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-20', 'studyFirstSubmitDate': '2025-07-20', 'studyFirstSubmitQcDate': '2025-07-20', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Striae Distensae Appearance', 'timeFrame': 'From enrollment to 12 months after treatment', 'description': 'Comparison of photographs before and after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Striae Distensae'], 'conditions': ['Striae Distensae']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a device works to treat striae distensae. It will also learn about the safety of the device. The main questions it aims to answer are:\n\n1. Does the device improve the appearance of striae distensae?\n2. Does the device cause any problems when treating striae distensae? Researchers will compare the appearance of striae distensae before and after treatment with the device.\n\nParticipants will:\n\n1. Undergo treatment with the device in the clinic\n2. Visit the clinic 1 week, 3 months, and 1 year for checkups and tests', 'detailedDescription': 'Participants will have the area of striae distensae anesthetized with local anesthetic. A biopsy will be performed and a device will be placed underneath the skin that will abrade the skin. Three months later another biopsy will be performed, photographs will be taken, and participants will fill out surveys to determine the effectiveness of the device to improve the appearance of the striae distensae.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Striae distensae\n\nExclusion Criteria:\n\n* Smoking, coagulation deficiency'}, 'identificationModule': {'nctId': 'NCT07087405', 'briefTitle': 'Striae Distensae Treatment Using Deep Skin Abrasion', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Stretch Mark Treatment Using Subcutaneous Skin Abrasion', 'orgStudyIdInfo': {'id': 'IRB-P00051021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Striae Distensae Treatment', 'description': 'Striae Distensae Treatment With A Device', 'interventionNames': ['Device: Striae Distensae Treatment Device']}], 'interventions': [{'name': 'Striae Distensae Treatment Device', 'type': 'DEVICE', 'description': 'One time deep skin treatment', 'armGroupLabels': ['Striae Distensae Treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Arin Greene, MD', 'role': 'CONTACT', 'email': 'arin.greene@childrens.harvard.edu', 'phone': '16173552306'}, {'name': 'Patrick Smits, PhD', 'role': 'CONTACT', 'email': 'patrick.smits@childrens.harvard.edu', 'phone': '6173552306'}], 'overallOfficials': [{'name': 'Arin Greene, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be aggregated'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Arin Greene', 'investigatorAffiliation': "Boston Children's Hospital"}}}}