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Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Orbital Fat Prolapse

Intervention: UltheraTM 100 shots (Device)

Phase: N/A

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Chanyeong Heo, Ph.D, Principal Investigator, Affiliation: Seoul National University Bundang Hospital


Study title

- Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design

- single arm and Investigator Initiative pilot study

Clinical Details

Official title: Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid,Phase 4.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The distance from the inferior orbital rim to the skin

Secondary outcome:

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

Subject Satisfaction for baggy lower eyelid

Improvement of baggy lower eyelid


Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Female.


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 and Contacts

Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu, Seongnam-si,, Gyeonggi-do 463-707, Korea, Republic of
Additional Information

Starting date: September 2012
Last updated: April 4, 2014

Page last updated: August 23, 2015

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