Treatment for Eye Bag Using Micro-insulated Needle Device

NCT03397758 | Completed

• 1 other identifier: B-1512/327-006
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sagging Eyelid Skin

Outcome Measures

Primary Outcomes (1)

• The changes of height of fat bulging

  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.

  up to 24weeks

Study Arms (1)

Study population

EXPERIMENTAL

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

Device: Study population

Interventions

Study population 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).

Also known as: AGNES (needle radiofrequency device)

Study population

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Related Publications (5)

• 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: 21674541 BACKGROUND

• 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: 22348573 BACKGROUND

• 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: 25099495 BACKGROUND

• 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: 25234835 BACKGROUND

• 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.

  PMID: 24398484 BACKGROUND

Study Officials

• Chang Hun Huh, MD, PhD

  Department of Dermatology, Seoul National University Bundang Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 12, 2018
• Study Start: May 1, 2015
• Primary Completion: October 31, 2016
• Study Completion: January 31, 2017
• Last Updated: January 17, 2018

Record last verified: 2017-12