Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid

Seoul National University

Status: Completed

Conditions: Orbital Fat Prolapse

Treatments: Device: UltheraTM 100 shots

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01693055

L-2012-408-3 (Other Grant/Funding Number)

E-1207/162-004

Details and patient eligibility

About

Study title

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

Enrollment: 7 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

UltheraTM

Experimental group

Description:

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

Treatment:

Device: UltheraTM 100 shots