Reducing Wrinkles Around the Eyes Using the Ulthera® System
The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes|
- Overall improvement in periorbital wrinkles [ Time Frame: 90 days post-treatment compared to baseline ] [ Designated as safety issue: No ]Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.
|Study Start Date:||March 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Ulthera System Treatment
Ulthera treatment to the upper face.
Device: Ulthera® System treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy
The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.
|United States, Maryland|
|MD Laser Skin & Vein Institute|
|Hunt Valley, Maryland, United States, 21030|
|United States, Tennessee|
|The Nashville Centre for Laser and Facial Surgery|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Robert Weiss, M.D.||MD Laser Skin & Vein Institute|
|Principal Investigator:||Brian Biesman, M.D.||The Nashville Centre for Laser and Facial Surgery|