Back to resultsLifting and Tightening of the Face and Neck Following an Increased Density Treatment
Primary Purpose
Skin Laxity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera System Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity focused on measuring Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged 30 to 65 years
- Subject in good health
- Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing
- Severe solar elastosis
- Excessive subcutaneous fat on the cheeks
- Excessive skin laxity on the lower face and neck
- Significant scarring in areas to be treated
- Significant open facial wounds or lesions
- Severe or cystic acne on the face
- Presence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants
Sites / Locations
- Laser & Skin Surgery Center of NY
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultherapy treatment
Arm Description
Ulthera System Treatment
Outcomes
Primary Outcome Measures
Improvement in Overall Lifting and Tightening of Skin
Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.
Secondary Outcome Measures
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse
Subjects' Assessment of Pain
Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.
Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment
Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01519206
Brief Title
Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
Official Title
Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ulthera, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.
Detailed Description
All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
Keywords
Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultherapy treatment
Arm Type
Experimental
Arm Description
Ulthera System Treatment
Intervention Type
Device
Intervention Name(s)
Ulthera System Treatment
Other Intervention Name(s)
Ultherapy™, Ulthera, Inc., Ultrasound treatment for skin tightening
Intervention Description
Focused ultrasound energy delivered below the surface of the skin.
Primary Outcome Measure Information:
Title
Improvement in Overall Lifting and Tightening of Skin
Description
Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.
Time Frame
Baseline to 90 days post treatment
Secondary Outcome Measure Information:
Title
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
Description
Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse
Time Frame
Baseline to 60 days, 90 days, 180 days and 1 year post-treatment
Title
Subjects' Assessment of Pain
Description
Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.
Time Frame
During Ulthera treatment
Title
Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment
Description
Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.
Time Frame
Baseline to 90 days, 180 days and 1 year post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female, aged 30 to 65 years
Subject in good health
Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Exclusion Criteria:
Presence of an active systemic or local skin disease that may affect wound healing
Severe solar elastosis
Excessive subcutaneous fat on the cheeks
Excessive skin laxity on the lower face and neck
Significant scarring in areas to be treated
Significant open facial wounds or lesions
Severe or cystic acne on the face
Presence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Geronemus, M.D.
Organizational Affiliation
Laser & Skin Surgery Center of NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laser & Skin Surgery Center of NY
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
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