Orbital Fat ProlapseNCT01693055
Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid
A study testing UltheraTM 100 shots in people with Orbital Fat Prolapse, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Study title Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design single arm and Investigator Initiative pilot study Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Orbital Fat Prolapse
- What is being tested?
- UltheraTM 100 shots
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >20 years, Age < 50 years
- people who want to improve baggy eyelid
- Information consent obtained
Who cannot join
- previous lower eyelid surgical history
- scar on lower eyelid after trauma
- bleeding tendency
- aesthetic addiction, drug abuse, alcohol abuse
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: 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
- Conditions
- Orbital Fat Prolapse
- Being tested
- UltheraTM 100 shots
- Keywords
- orbital Computed Tomography, baggy eyelids, orbital fat prolapse, UltheraTM, high intensity focused ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltheraTM 100 shotsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: UltheraTM 100 shots |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Screening in distance at 12weeks after Ulthera treatment
Secondary outcomes (3)
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
Measured: Change from Screening in distance at 12weeks after UltheraTM 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).
Measured: 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
- mild
- moderate
- marked
- severe
Measured: Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital Fat ProlapseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ulthera, Inc
- Responsible party
- Principal investigator, Chan-Yeong Heo, Seoul National University Hospital
- Investigators
- Chanyeong Heo, Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693055
- Sponsor's protocol ID
- E-1207/162-004
- Other IDs
- L-2012-408-3
- Status last verified
- Apr 2014
- First submitted
- 18 Sep 2012
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid,Phase 4.
- ClinicalTrials.gov ID
- NCT01693055
- Acronym / sponsor ID
- E-1207/162-004
- Conditions
- Orbital Fat Prolapse
- Keywords
- orbital Computed Tomography, baggy eyelids, orbital fat prolapse, UltheraTM, high intensity focused ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ulthera, Inc
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study title
- Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design
- single arm and Investigator Initiative pilot study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UltheraTM | Experimental | Device: UltheraTM 100 shotsUltheraTM 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age >20 years, Age < 50 years
- people who want to improve baggy eyelid
- Information consent obtained
Key exclusion criteria (4 listed)
- previous lower eyelid surgical history
- scar on lower eyelid after trauma
- bleeding tendency
- aesthetic addiction, drug abuse, alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltheraTM 100 shotsUltheraTM 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 |
Primary outcome
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
3 secondary outcomes
The distance from the most protrusive baggy eyelid to the orbital septum
Time frame: 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
Improvement of baggy lower eyelid
Time frame: Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanyeong Heo, Ph.D principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UltheraTM 100 shots in people with Orbital Fat Prolapse, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distance from the inferior orbital rim to the skin (time frame: Change from Screening in distance at 12weeks after Ulthera treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.