Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01708512|
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Skin Laxity||Device: Ulthera System Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatment Approach|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||July 2013|
Experimental: Ultherapy™ study treatment
Each subject will receive a customized, high-density, vectored Ulthera System Treatment.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
- Improvement in overall lifting and tightening of the skin [ Time Frame: 90 days post-treatment ]As determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline. The clinical response of Ulthera treatment will be assessed by comparing photographic images taken before and after the procedure.
- Overall aesthetic improvement [ Time Frame: 365 days post-treatment ]Global Aesthetic Improvement Scale scores will be obtained from the Investigator and subject, assessing improvement in skin laxity based on a comparison of post-treatment photos to pre-treatment photos.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708512
|United States, Washington|
|Premier Clinical Research|
|Spokane, Washington, United States, 99204|
|Principal Investigator:||William P Werschler, MD|