Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid

April 4, 2014 updated by: Chan-Yeong Heo, Seoul National University Hospital

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

Study title

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: UltheraTM
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
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The distance from the inferior orbital rim to the skin
Time Frame: 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
Change from Screening in distance at 12weeks after Ulthera treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ulthera, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (ESTIMATE)

September 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-1207/162-004
  • L-2012-408-3 (OTHER_GRANT: JOYMG Co.,Ltd)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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