Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-02-27 @ 5:17 PM
Study NCT ID:
NCT04742803
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2020-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Straberi Epistamp Needling Treatment For Skin Rejuvenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-07', 'releaseDate': '2025-09-18'}], 'estimatedResultsFirstSubmitDate': '2025-09-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004535', 'term': 'Ehlers-Danlos Syndrome'}], 'ancestors': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Global Aesthetic Improvement Scale (GAIS)', 'timeFrame': '6 months', 'description': 'The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator 5 point scale ranging from 1 to 5 with 5 = The appearance has worsen compared with the original condition and 1 = Excellent corrective results investigator.'}], 'secondaryOutcomes': [{'measure': 'Overall Skin improvement assessed by Derma Scan', 'timeFrame': '6 months', 'description': 'The Derma Scan System utilizes two special lighting systems (RGB +UV) and smart skin analyzer software that allows two images (before and after care) to be compared side by side, which can be used to detect the changes in skin.'}, {'measure': 'Photographs', 'timeFrame': '6 months', 'description': 'Digital imaging device using a grid background with controlled lighting and setting to grade acne scar improvement on a quartile grading scale(1 = 1% to 25%, 2 = 26 to 50%, 3 = 51 to 75%, 4 = \\>76% improvement).'}, {'measure': 'To evaluate the impact on the quality of life (DLQI)', 'timeFrame': '6 months', 'description': 'The Dermatology Life Quality Index questionnaire (DLQI) is 10 questions were asked to the patients and score is 0-3 for each question. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.'}, {'measure': 'Wrinkle Severity Rating Scale (WSRS)', 'timeFrame': '6 months', 'description': 'The Wrinkle Severity Rating Scale assesses the presence and severity of wrinkles at rest in a rating scale from 0 to 4, where 0 means no visible wrinkles, 1 means minimal wrinkles, 2 means shallow wrinkles, 3 means moderately deep wrinkles and 4 means very deep wrinkles.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['microneedling'], 'conditions': ['Wrinkle', 'Elastic Skin', 'Collagen Degeneration']}, 'referencesModule': {'references': [{'pmid': '17199653', 'type': 'BACKGROUND', 'citation': 'Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.'}, {'pmid': '8033378', 'type': 'BACKGROUND', 'citation': 'Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.'}], 'seeAlsoLinks': [{'url': 'http://universalskincareinstitute.com/', 'label': 'Derma Scan'}]}, 'descriptionModule': {'briefSummary': 'This pilot study will expand knowledge and application needling using the Epistamp device for the improvement of a new vitalized epidermal layer with new vibrant active cells, supported by more robust collagen and elastin fine lines, deep wrinkles, and collagen production.', 'detailedDescription': 'This pilot study will expand the knowledge and application needling using the Epistamp device and its benefits for improving the appearance of fine lines, deep wrinkles, and collagen production. The pilot aims to objectively measure skin quality using the Derma Scan, photographs and provide objective data showing improvement by way of the Universal Skincare Institute Blood Flow Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Derma Scan showing aging including skin texture, wrinkles, brown spots, and pores.\n* Patients willing to sign informed consent.\n* Patients willing to be photographed and video documented\n* Patients willing to consent to 3 months of treatment\n\nExclusion Criteria:\n\n* History of eczema in the treatment area; psoriasis and any other chronic skin conditions\n* History of actinic (solar) keratosis in the treatment area;\n* History of hemophilia\n* History of diabetes\n* The presence of raised moles, warts on the targeted area.\n* Collagen vascular diseases or cardiac abnormalities\n* Blood clotting problems\n* Active bacterial or fungal infection\n* Facial melanosis\n* Malignant tumors\n* Immunosuppression\n* Use of blood thinners or prednisone\n* Corticosteroids within two weeks of the procedure\n* Chronic liver disease\n* Porphyria or other skin diseases.\n* Patient not willing to sign informed consent.\n* TCA peels in the last 5 weeks\n* Subject currently has moderate to severe acne on the face.\n* Microneedling within the last 6 months\n* Subject has an active infection.\n* Subject has a history of a bleeding disorder\n* Subject has a history of keloidal tendency\n* Subject has received ablative or non-ablative laser treatments in the previous 6 months.\n* Subject has taken Accutane within the previous 3 months.'}, 'identificationModule': {'nctId': 'NCT04742803', 'acronym': 'ESAA', 'briefTitle': 'Straberi Epistamp Needling Treatment For Skin Rejuvenation', 'organization': {'class': 'OTHER', 'fullName': 'Universal Skincare Institute'}, 'officialTitle': 'Face Study of the Effects of Needling Using the Straberi Epistamp for the Improvement of Fine Lines and Skin Laxity.', 'orgStudyIdInfo': {'id': '1116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Straberi Epistamp Needling Treatment', 'description': 'Non-Randomized treatment for patients who seek improvement for elastin, fine lines, deep wrinkles, and collagen production using Straberi Epistamp needling treatment', 'interventionNames': ['Device: Straberi Epistamp Microneedling Treatment']}, {'type': 'OTHER', 'label': 'No Treatment', 'description': 'Non-Randomized patients who seek improvement for elastin, fine lines, deep wrinkles, and collagen production.', 'interventionNames': ['Device: Straberi Epistamp Microneedling Treatment']}], 'interventions': [{'name': 'Straberi Epistamp Microneedling Treatment', 'type': 'DEVICE', 'otherNames': ['Needling'], 'description': "The patient's entire face will be treated with the Straberi Epistamp needling device.\n\nThe following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm", 'armGroupLabels': ['No Treatment', 'Straberi Epistamp Needling Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lavish', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Maurice Wright, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University/ Harlem Hospital'}, {'name': 'Leslie L Nesbitt', 'role': 'STUDY_CHAIR', 'affiliation': 'Universal Skincare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Once the overall trial is completed and sensitive detailed information is legally advised to published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universal Skincare Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lavish Beauty', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-18', 'type': 'RELEASE'}, {'date': '2025-10-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Universal Skincare Institute'}}}}