Back to resultsFeasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees
Primary Purpose
Skin Laxity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera® System
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity focused on measuring Skin laxity, Knees
Eligibility Criteria
Inclusion Criteria:
- Female, aged 30 to 65 years.
- Subject in good health.
- Mild to moderate skin laxity around the knees.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing.
- Excessive subcutaneous fat around the knees.
- Excessive skin laxity around the knees.
Sites / Locations
- Tennessee Clinical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ulthera® treatment of the knees
Arm Description
Bilateral treatment of the knees using the Ulthera® System
Outcomes
Primary Outcome Measures
Improvement in overall lifting and tightening of knee skin laxity.
Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.
Secondary Outcome Measures
Overall improvement in skin laxity.
Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01708434
Brief Title
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees
Official Title
Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
August 2012 (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
Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.
Detailed Description
This pilot study is a prospective, single-center clinical trial of the Ulthera® System for treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient Satisfaction questionnaires will be obtained at each follow-up visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
Keywords
Skin laxity, Knees
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ulthera® treatment of the knees
Arm Type
Experimental
Arm Description
Bilateral treatment of the knees using the Ulthera® System
Intervention Type
Device
Intervention Name(s)
Ulthera® System
Other Intervention Name(s)
Ultherapy™ treatment
Intervention Description
Focused ultrasound energy delivered below the surface of the skin
Primary Outcome Measure Information:
Title
Improvement in overall lifting and tightening of knee skin laxity.
Description
Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.
Time Frame
90 and 180 days post-treatment
Secondary Outcome Measure Information:
Title
Overall improvement in skin laxity.
Description
Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire.
Time Frame
90 and 180 days post-treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female, aged 30 to 65 years.
Subject in good health.
Mild to moderate skin laxity around the knees.
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Exclusion Criteria:
Presence of an active systemic or local skin disease that may affect wound healing.
Excessive subcutaneous fat around the knees.
Excessive skin laxity around the knees.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gold, MD
Organizational Affiliation
Tennessee Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25065380
Citation
Gold MH, Sensing W, Biron J. Use of micro-focused ultrasound with visualization to lift and tighten lax knee skin (1.). J Cosmet Laser Ther. 2014 Oct;16(5):225-9. doi: 10.3109/14764172.2014.949273. Epub 2014 Sep 2. Erratum In: J Cosmet Laser Ther. 2015;17(5):290.
Results Reference
derived
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Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees
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