Back to resultsEvaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
Primary Purpose
Mild to Moderate Skin Laxity on Cheek, Mild to Moderate Skin Laxity on Upper Neck, Mild to Moderate Subcutaneous Fat on Cheek
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ulthera treatment
Sponsored by
About this trial
This is an interventional treatment trial for Mild to Moderate Skin Laxity on Cheek
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ulthera treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01368835
First Posted
June 6, 2011
Last Updated
November 16, 2017
Sponsor
Ulthera, Inc
Collaborators
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01368835
Brief Title
Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ulthera, Inc
Collaborators
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ulthera treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ulthera treatment
Intervention Description
treatment of cheeks and upper neck area of face
Primary Outcome Measure Information:
Title
Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.
Description
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.
Time Frame
90D
Secondary Outcome Measure Information:
Title
Change in Submental and Neck Skin Laxity by Quantitative Analysis
Description
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.
Time Frame
90D
Title
Patient Satisfaction Questionnaire
Description
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.
Time Frame
90D
Other Pre-specified Outcome Measures:
Title
Subject Assessment of Pain
Description
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.
Time Frame
During Ulthera study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M. Kenkel, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
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