Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid

Seoul National University Hospital7 enrolled

Overview

Study title * Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design * single arm and Investigator Initiative pilot study

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Orbital Fat Prolapse

Interventions

UltheraTM 100 shotsDEVICE

UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>20 years, Age \< 50 years * people who want to improve baggy eyelid * Information consent obtained Exclusion Criteria: * previous lower eyelid surgical history * scar on lower eyelid after trauma * bleeding tendency * aesthetic addiction, drug abuse, alcohol abuse

Locations (1)

Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

The distance from the inferior orbital rim to the skin

Difference between the distance ( from the inferior orbital rim to the skin) measured by orbital CT at Screening and 12weeks after UltheraTM treatment

Time frame: Change from Screening in distance at 12weeks after Ulthera treatment

Secondary Outcomes

The distance from the most protrusive baggy eyelid to the orbital septum

The distance(mm),from the most protrusive baggy eyelid to the orbital septum will be measured by a plastic surgeon with orbital CT films. Each participant will do Orbital CT scan 2 times, at screening and 12weeks after treatment

Time frame: Change from Screening in distance at 12weeks after UltheraTM treatment

Subject Satisfaction for baggy lower eyelid

5-point scale for Subject Satisfaction in baggy lower eyelid. The subject satisfaction is calculated as a score between 0 and 4( 0= very poor, 4= very good).

Time frame: Change from Screening in satisfaction at 4 weeks and 12weeks

Improvement of baggy lower eyelid

Improvement of baggy lower eyelid will be assessed by Two plastic surgeons. Both assessors will evaluate Improvement of baggy lower eyelid including skin laxity and orbital fat prolapse using 5-point scale. 0= no involvement 1. mild 2. moderate 3. marked 4. severe

Time frame: Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment

Data from ClinicalTrials.gov

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