Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue

Evaluation of the Ulthera™ System For Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity

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

Study Overview

• Status: Completed
• Conditions: 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
• Intervention / Treatment: Device: Ulthera treatment

Detailed Description

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
• Enrollment (Actual): 103
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, aged 35 to 60 years
• Subject in good health
• Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity

Exclusion Criteria:

• Pregnant or lactating
• Has an active systemic or local skin disease that may alter wound healing
• Severe solar elastosis
• Excessive subcutaneous fat on the cheeks
• Excessive skin laxity on the lower face and neck
• Has significant scarring in areas to be treated
• Has significant open facial wounds or lesions
• Has severe or cystic acne on the face

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ulthera treatment	Device: Ulthera treatment; treatment of cheeks and upper neck area of face

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.	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.	90D

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Submental and Neck Skin Laxity by Quantitative Analysis	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.	90D
Patient Satisfaction Questionnaire	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.	90D

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Assessment of Pain	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.	During Ulthera study treatment

Collaborators and Investigators

• Sponsor: Ulthera, Inc
• Collaborators: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Jeffrey M. Kenkel, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: ULT-106