Back to resultsSafety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid
Primary Purpose
Orbital Fat Prolapse
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
UltheraTM 100 shots
Sponsored by
About this trial
This is an interventional treatment trial for Orbital Fat Prolapse focused on measuring orbital Computed Tomography, baggy eyelids, orbital fat prolapse, UltheraTM, high intensity focused ultrasound
Eligibility 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
Sites / Locations
- Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UltheraTM
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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).
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
mild
moderate
marked
severe
Full Information
NCT ID
NCT01693055
First Posted
September 18, 2012
Last Updated
April 4, 2014
Sponsor
Seoul National University Hospital
Collaborators
Ulthera, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01693055
Brief Title
Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid
Official Title
Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid,Phase 4.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ulthera, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study title
Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design
single arm and Investigator Initiative pilot study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orbital Fat Prolapse
Keywords
orbital Computed Tomography, baggy eyelids, orbital fat prolapse, UltheraTM, high intensity focused ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UltheraTM
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
UltheraTM 100 shots
Intervention Description
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 Measure Information:
Title
The distance from the inferior orbital rim to the skin
Description
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 Outcome Measure Information:
Title
The distance from the most protrusive baggy eyelid to the orbital septum
Description
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
Title
Subject Satisfaction for baggy lower eyelid
Description
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
Title
Improvement of baggy lower eyelid
Description
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
mild
moderate
marked
severe
Time Frame
Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chanyeong Heo, Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu
City
Seongnam-si,
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid
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