Treatment for Eye Bag Using Micro-insulated Needle Device

NCT ID: NCT03397758

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-01
• Study Completion Date: 2017-01-31

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.

Conditions

Sagging Eyelid Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study population

They were treated with AGNES micro-insulated needles with RF applicators in two separate sessions, at intervals of four weeks.

Group Type: EXPERIMENTAL

Study population

Intervention Type: DEVICE

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).

Interventions

Study population

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).

Intervention Type: DEVICE

Other Intervention Names

AGNES (needle radiofrequency device)

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chang Hun Huh, MD, PhD

Role: STUDY_CHAIR

Department of Dermatology, Seoul National University Bundang Hospital

References

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.

Reference Type: BACKGROUND

PMID: 21674541 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22348573 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25099495 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25234835 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24398484 (View on PubMed)

Other Identifiers

B-1512/327-006

Identifier Type: -

Identifier Source: org_study_id