Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin
Mild to Moderate Skin Laxity on Cheek
Mild to Moderate Skin Laxity on Upper Neck
Mild to Moderate Subcutaneous Fat on Cheek
Mild to Moderate Subcutaneous Fat on Upper Neck
Device: Ulthera treatment
|Study Design:||Endpoint Classification: 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|
- Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions. [ Time Frame: 90D ] [ Designated as safety issue: No ]The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.
- Change in Submental and Neck Skin Laxity by Quantitative Analysis [ Time Frame: 90D ] [ Designated as safety issue: No ]The percentage of participants assessed as having an improvement in tissue lift, i.e., >20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis.
- Patient Satisfaction Questionnaire [ Time Frame: 90D ] [ Designated as safety issue: No ]Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.
- Subject Assessment of Pain [ Time Frame: During Ulthera study treatment ] [ Designated as safety issue: Yes ]Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.
|Study Start Date:||July 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Experimental: Ulthera treatment||
Device: Ulthera treatment
treatment of cheeks and upper neck area of face
The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue.
The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.