Clinical trial NCT03397758: Treatment for Eye Bag Using Micro-insulated Needle Device
Official title: Non-surgical Treatment for Eye Bag Using AGNES(Radiofrequency Device) With Micro-insulated Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sagging Eyelid Skin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy adult with age of 40s or more
* Who has lower eyelid fat bulging

Exclusion Criteria:

* History of keloid or hypertrophic scar
* Pregnant woman,
* On breast feeding
* Active skin disease on lesional skin
* Who has severe allergy
* History of bleeding disorder

Primary outcomes:
measure: The changes of height of fat bulging
timeFrame: up to 24weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Dermatology, Seoul National University Bundang Hospital
name: Chang Hun Huh, MD, PhD
role: STUDY_CHAIR
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