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Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid

This study has been completed.
Sponsor:
Collaborator:
Ulthera, Inc
Information provided by (Responsible Party):
Chan-Yeong Heo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01693055
First received: September 18, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

Study title

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

Condition Intervention
Orbital Fat Prolapse
 Device: UltheraTM 100 shots

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid,Phase 4.

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The distance from the inferior orbital rim to the skin [ Time Frame: Change from Screening in distance at 12weeks after Ulthera treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Change from Screening in distance at 12weeks after UltheraTM treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from Screening in satisfaction at 4 weeks and 12weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment ] [ Designated as safety issue: No ]

    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

    1. mild
    2. moderate
    3. marked
    4. severe


Enrollment: 7
Study Start Date: September 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UltheraTM
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
 Device: UltheraTM 100 shots
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693055

Locations
Korea, Republic of
Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu
Seongnam-si,, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Ulthera, Inc
Investigators
Principal Investigator: Chanyeong Heo, Ph.D Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Chan-Yeong Heo, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01693055     History of Changes
Other Study ID Numbers: E-1207/162-004, L-2012-408-3
Study First Received: September 18, 2012
Last Updated: March 18, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
orbital Computed Tomography
baggy eyelids
orbital fat prolapse
UltheraTM
high intensity focused ultrasound

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013