Orbital Fat Prolapse Clinical Trial
Official title:
Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid,Phase 4.
| Verified date | April 2014 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Interventional |
Study title
- Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design
- single arm and Investigator Initiative pilot study
| Status | Completed |
| Enrollment | 7 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 50 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu | Seongnam-si, | Gyeonggi-do |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital | Ulthera, Inc |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 |
Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment | No |