Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT05685667
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2022-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Needless Laser Injector for Antiaging Effect of Dermal Filler
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009339', 'term': 'Needles'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin hydration using a Corneometer® CM 825', 'timeFrame': 'at 12 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'Skin elasticity using a Cutometer® MPA 580', 'timeFrame': 'at 12 weeks after treatment'}, {'measure': 'Erythema index (EI) using a Mexameter® MX 18 (Courage & Khazaka)', 'timeFrame': 'at 12 weeks after treatment'}, {'measure': 'Skin aging analyzed by three-dimensional photogrammetry', 'timeFrame': 'at 12 weeks after treatment'}, {'measure': "Patient's satisfaction score for antiaging effects", 'timeFrame': 'at 12 weeks after treatment', 'description': 'from 1 (extremely dissatisfied) to 7 (extremely satisfied)'}, {'measure': "Patient's pain score during treatment", 'timeFrame': 'up to 24 weeks', 'description': 'from 0 (none) to 10 (worst)'}, {'measure': 'Adverse events related to the procedure', 'timeFrame': 'up to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging Problems']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to evaluate the efficacy and safety of needless laser injector for antiaging effect of dermal filler.', 'detailedDescription': 'A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of needless laser injector versus needle injection for anti-aging effect of dermal filler.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who wanted to improve facial skin aging\n\nExclusion Criteria:\n\n* a history of skin rejuvenation treatment (including filler, botulinum toxin, lasers, chemical peeling, and topical retinoid) within 6 month prior to the start of the study\n* having a plan for skin rejuvenation treatment during the study\n* current pregnancy or breastfeeding\n* an allergy to polylactic acid (PLA) or hyaluronic acid (HA)\n* uncontrolled medical diseases'}, 'identificationModule': {'nctId': 'NCT05685667', 'briefTitle': 'Needless Laser Injector for Antiaging Effect of Dermal Filler', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Needless Laser Injector Versus Needle Injection for Antiaging Effect of Dermal Filler: A Randomized Split-face Comparison', 'orgStudyIdInfo': {'id': 'MIRAJET-KHIDI-2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser-induced microjet injector (Mirajet)', 'description': 'The left/right assignment was sealed in a nontransparent envelop.', 'interventionNames': ['Device: needless laser injector (Mirajet)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Needle injection (control)', 'description': 'The left/right assignment was sealed in a nontransparent envelop.', 'interventionNames': ['Device: needle injection']}], 'interventions': [{'name': 'needless laser injector (Mirajet)', 'type': 'DEVICE', 'otherNames': ['polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler'], 'description': 'Mirajet injection was performed 2-3 passes until a total of 2cc of diluted PLA/HA solution was completely injected to the one half of the face.', 'armGroupLabels': ['Laser-induced microjet injector (Mirajet)']}, {'name': 'needle injection', 'type': 'DEVICE', 'otherNames': ['polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler'], 'description': 'For traditional method of needle injection, intradermal injection using multi-puncture/micro-papule technique was used. A series of injections at 0.5-1 cm apart was performed on one half of the face so that a total of 2cc of diluted PLA/HA solution was injected.', 'armGroupLabels': ['Needle injection (control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'overallOfficials': [{'name': 'Jung Won Shin, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jung-Won Shin', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}