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OpenTrials
Completed

NCT Number: NCT01693055

Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid

Study title

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

Completed

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Key information

Conditions

Orbital Fat Prolapse

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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).

  3. 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

    • mild
    • moderate
    • marked
    • severe

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ulthera, Inc

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2012
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.