Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-22 @ 9:36 AM
Study NCT ID:
NCT03397758
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2017-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment for Eye Bag Using Micro-insulated Needle Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-15', 'studyFirstSubmitDate': '2017-12-18', 'studyFirstSubmitQcDate': '2018-01-11', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes of height of fat bulging', 'timeFrame': 'up to 24weeks', 'description': 'To height of fat bulging was determined as an arbitrary reference plane that links the three points: two points where the right and the left mid pupillary lines meet at each lower eyelid, and the other one point at the pogonion (the most anterior part on the chin). Then, the distance from this reference plane to the highest point of fat bulging was defined as the height of fat bulging.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sagging Eyelid Skin']}, 'referencesModule': {'references': [{'pmid': '21674541', 'type': 'BACKGROUND', 'citation': 'Chan NP, Shek SY, Yu CS, Ho SG, Yeung CK, Chan HH. Safety study of transcutaneous focused ultrasound for non-invasive skin tightening in Asians. Lasers Surg Med. 2011 Jul;43(5):366-75. doi: 10.1002/lsm.21070.'}, {'pmid': '22348573', 'type': 'BACKGROUND', 'citation': 'Lee JW, Kim BJ, Kim MN, Ahn GY, Aso H. Selective sebaceous gland electrothermolysis as a treatment for acne: a prospective pilot study. Int J Dermatol. 2012 Mar;51(3):339-44. doi: 10.1111/j.1365-4632.2011.05255.x.'}, {'pmid': '25099495', 'type': 'BACKGROUND', 'citation': 'Pak CS, Lee YK, Jeong JH, Kim JH, Seo JD, Heo CY. Safety and efficacy of ulthera in the rejuvenation of aging lower eyelids: a pivotal clinical trial. Aesthetic Plast Surg. 2014 Oct;38(5):861-8. doi: 10.1007/s00266-014-0383-6. Epub 2014 Aug 7.'}, {'pmid': '25234835', 'type': 'BACKGROUND', 'citation': 'Akita H, Sasaki R, Yokoyama Y, Negishi K, Matsunaga K. The clinical experience and efficacy of bipolar radiofrequency with fractional photothermolysis for aged Asian skin. Exp Dermatol. 2014 Oct;23 Suppl 1:37-42. doi: 10.1111/exd.12391.'}, {'pmid': '24398484', 'type': 'BACKGROUND', 'citation': 'Bernardini FP, Cetinkaya A, Devoto MH, Zambelli A. Calcium hydroxyl-apatite (Radiesse) for the correction of periorbital hollows, dark circles, and lower eyelid bags. Ophthalmic Plast Reconstr Surg. 2014 Jan-Feb;30(1):34-9. doi: 10.1097/IOP.0000000000000001.'}]}, 'descriptionModule': {'briefSummary': 'The investigators treated twenty-four subjects with lower eyelid fat bulging using the needle radiofrequency system. After treatment, a three-dimensional photogrammetry system was used to objectively measure the change in height of the fat bulge.', 'detailedDescription': 'Materials and Methods\n\nSubjects\n\nTwenty-four volunteers (4 males and 20 females) with lower eyelid fat bulging were enrolled in this study. The average age of these subjects was 56±6.28 years. The exclusion criteria were as follows: Prior cosmetic facial surgery within the past 1 year, placement of tissue fillers within the last 6 months, laser therapy or chemical peeling of midface within the preceding 3 months, and the use of topical retinoids for the face within the past 1 month. The study protocol was approved by the institutional review board Seoul National University Bundang Hospital and informed consent was obtained from all subjects prior to participation.\n\nTreatment protocol\n\nAll treatments were performed under local anesthesia with 1% lidocaine and 1:100,000 epinephrine. To minimize the impact on the treatment area, the least amount of anesthesia required was injected. The amount of AGNES micro-insulated needles with radiofrequency applicators (Gowoonsesang Cosmetics Co, Seongnam, Gyeonggi, Korea) were used to treat the lesions. This device is a monopolar radiofrequency system with 1MHz wavelength. The needles were composed of two parts: The proximal insulated area and the distal non-insulated area. Proximal insulation preserves the epidermis from thermal damage, allowing the procedure to be non-ablative and minimally-invasive.\n\nSubjects were treated in two separate sessions, at intervals of four weeks. Two types of needle tips were used sequentially in each session; one is a tip with three 1.5mm-length short needles with proximal 0.3mm insulation, while the other is a tip with single 5mm-length long needle with proximal 2.5mm insulation. First, periorbital area was treated with the short needles (exposure time 150ms, power 9W) to tighten the overlying dermis. Then, the fat pocket itself was treated additionally with the long needle (exposure time 400ms, power 9W) to tighten the orbital septum and directly damage the fat cells. Each insertion site was about 1mm apart. After treatment, the treated areas were cooled with ice packs for 20min and topical antibiotic was applied. All subjects were instructed to cleanse their face gently with tap water and avoid sun exposure until next day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult with age of 40s or more\n* Who has lower eyelid fat bulging\n\nExclusion Criteria:\n\n* History of keloid or hypertrophic scar\n* Pregnant woman,\n* On breast feeding\n* Active skin disease on lesional skin\n* Who has severe allergy\n* History of bleeding disorder'}, 'identificationModule': {'nctId': 'NCT03397758', 'briefTitle': 'Treatment for Eye Bag Using Micro-insulated Needle Device', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Non-surgical Treatment for Eye Bag Using AGNES(Radiofrequency Device) With Micro-insulated Needle', 'orgStudyIdInfo': {'id': 'B-1512/327-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study population', 'description': 'They were treated with AGNES micro-insulated needles with RF applicators in two separate sessions, at intervals of four weeks.', 'interventionNames': ['Device: Study population']}], 'interventions': [{'name': 'Study population', 'type': 'DEVICE', 'otherNames': ['AGNES (needle radiofrequency device)'], 'description': 'First, periorbital area was treated with the short needles (exposure time 150ms, power 9W) to tighten the overlying dermis. Then, the fat pocket itself was treated additionally with the long needle (exposure time 400ms, power 9W).', 'armGroupLabels': ['Study population']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chang Hun Huh, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Dermatology, Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}