Lifting and Tightening of the Face in Subjects With Skin of Darker Color
This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.
|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 Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients With Fitzpatrick Skin Phototypes 3 Through 6|
- Improvement in overall lifting and tightening of skin [ Time Frame: 90 days post treatment compared to baseline ] [ Designated as safety issue: No ]Improvement in overall lifting and tightening of skin as determined by masked qualitative assessment of 90 day post treatment photographs compared to baseline.
|Study Start Date:||March 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Experimental: Ulthera® System treatment||
Device: Ulthera® System treatment
Ulthera® System treatment delivering focused ultrasound energy
The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.
|United States, Maryland|
|Harris Aesthetics, LLC|
|Chevy Chase, Maryland, United States, 20815|
|Dermatology, Cosmetic & Laser Surgery|
|Rockville, Maryland, United States, 20852|
|Principal Investigator:||Hema Sundaram, M.D.||Dermatology, Cosmetic & Laser Surgery|
|Principal Investigator:||Monte O Harris, M.D.||Harris Aesthetics, LLC|