Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-29 @ 4:18 AM
Study NCT ID:
NCT05819450
Status:
UNKNOWN
Last Update Posted:
2023-08-30
First Post:
2023-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonography-Guided Volumetric Rejuvenation on Dorsal Hands
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aesthetic improvement', 'timeFrame': 'Day 0, 30, 180 follow up', 'description': '5-point global aesthetic improvement scales scoring (Min:1; Max:5)'}], 'secondaryOutcomes': [{'measure': 'Thickness of the fatty laer', 'timeFrame': 'Day 0, 30, 180 follow up', 'description': 'Thickness of the dorsal superficial lamina (DSL) and dorsal intermediate lamina (DIL)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cosmetic', 'Volumetric rejuvenation', 'Filler', 'Dorsal hand', 'Ultrasound'], 'conditions': ['Ultrasound', 'Injection Site']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled study is to guide volumetric rejuvenation on dorsal hands with the maximal aesthetic appearance. The main questions it aims to answer are:\n\n* Which fatty layer(s) is/are the most suitable for filler injection?\n* Is it feasible to make precise filler injections with sonography guidance? Participants will receive sonography-guided injection on the one hand and another with blinded injection.', 'detailedDescription': 'In our previous study, volumetric fat loss was noted in the 3 fatty laminae of dorsal hands during aging; the dorsal intermediate lamina (DIL) showed the greatest progressive fat loss after the age of 30. Volumetric rejuvenation of the 3 laminae may result in the most aesthetic appearance, especially in women. It is necessary to develop precise rejuvenation therapies according to the aging process of the dorsum of the hands that will yield the most aesthetic appearance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of aging changes on the dorsal hands\n* Aged ≥18 years\n\nExclusion Criteria:\n\n* History of severe hand dermatitis\n* History of rheumatic arthritis\n* History of major hand trauma\n* History of limb edema\n* History of recent significant weight changes\n* History of previous filler injection to the dorsal hands\n* History of intravenous catheter insertion and hemodialysis via the forearms or hands'}, 'identificationModule': {'nctId': 'NCT05819450', 'briefTitle': 'Sonography-Guided Volumetric Rejuvenation on Dorsal Hands', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Sonography-Guided Volumetric Rejuvenation on Dorsal Hands: A Split-Hand Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '202101547B0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sonography-guided hand', 'description': 'One hand of the participant will be treated with sonography-guided filler injection in random', 'interventionNames': ['Procedure: Volumetric rejuvenation']}, {'type': 'NO_INTERVENTION', 'label': 'Blinded injected hand', 'description': "One hand of the participant will be treated with filler injection by physician's experience without sonography-guidance in random"}], 'interventions': [{'name': 'Volumetric rejuvenation', 'type': 'PROCEDURE', 'description': 'Volumetric Rejuvenation with FDA-approved fillers on the skin of the dorsal hands', 'armGroupLabels': ['Sonography-guided hand']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marbella', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Gabriela Casabona, MD', 'role': 'CONTACT', 'email': 'grcasabona@gmail.com'}], 'facility': 'Ocean Clinic Marbella', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '333', 'city': 'Taoyuan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yi-Teng Hung, MD', 'role': 'CONTACT', 'email': 'herovincent25@hotmail.com.tw', 'phone': '+886972392650'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'centralContacts': [{'name': 'Yi-Teng Hung, MD', 'role': 'CONTACT', 'email': 'herovincent25@hotmail.com.tw', 'phone': '+886972392650'}], 'overallOfficials': [{'name': 'Yi-Teng Hung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Fellow', 'investigatorFullName': 'Yi-Teng Hung', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}