Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| L-2012-408-3 | Other Grant/Funding Number | JOYMG Co.,Ltd |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ulthera, Inc | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study title
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UltheraTM | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UltheraTM 100 shots | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from Screening in distance at 12weeks after Ulthera treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from Screening in distance at 12weeks after UltheraTM treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chanyeong Heo, Ph.D | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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). | Change from Screening in satisfaction at 4 weeks and 12weeks |
| 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
| Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment |