Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
|ClinicalTrials.gov Identifier: NCT01368835|
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : August 15, 2013
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||April 2011|
|Experimental: Ulthera treatment||
Device: Ulthera treatment
treatment of cheeks and upper neck area of face
- Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions. [ Time Frame: 90D ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368835
|Principal Investigator:||Jeffrey M. Kenkel, MD||University of Texas Southwestern Medical Center|