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
Summary
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 septumSubject Satisfaction for baggy lower eyelid Improvement of baggy lower eyelid
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
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
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