NCT Number: NCT03397758
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.
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Materials and Methods
Subjects
Twenty-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.
Treatment protocol
All 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.
Subjects 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: AGNES (needle radiofrequency device)
Time frame: up to 24weeks
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.
Seoul National University Hospital
Other
Non-surgical Treatment for Eye Bag Using AGNES(Radiofrequency Device) With Micro-insulated Needle
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