Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid

Not Applicable

Completed

• Conditions: Orbital Fat Prolapse
• Interventions: Device: UltheraTM 100 shots

• Registration Number: NCT01693055
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Study title

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

* single arm and Investigator Initiative pilot study

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-26
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

• Age >20 years, Age < 50 years
• people who want to improve baggy eyelid
• Information consent obtained

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Exclusion Criteria

• previous lower eyelid surgical history
• scar on lower eyelid after trauma
• bleeding tendency
• aesthetic addiction, drug abuse, alcohol abuse

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UltheraTM	UltheraTM 100 shots	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

Primary Outcome Measures

Name	Time	Method
The distance from the inferior orbital rim to the skin	Change from Screening in distance at 12weeks after Ulthera treatment	Difference between the distance ( from the inferior orbital rim to the skin) measured by orbital CT at Screening and 12weeks after UltheraTM treatment

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction for baggy lower eyelid	Change from Screening in satisfaction at 4 weeks and 12weeks	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).
The distance from the most protrusive baggy eyelid to the orbital septum	Change from Screening in distance at 12weeks after UltheraTM treatment	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
Improvement of baggy lower eyelid	Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment	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

Trial Locations

Locations (1)

Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu; 🇰🇷 Seongnam-si,, Gyeonggi-do, Korea, Republic of