Back to resultsFeasibility Study: Lifting and Tightening of the Elbows
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., Ultrasound treatment for skin tightening
Eligibility Criteria
Inclusion Criteria:
- Male or female, age 21 to 65 years.
- Subject in good health.
- Mild to moderate skin laxity on the elbows.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up 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.
- Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing.
- Excessive subcutaneous fat around the elbows.
- Excessive skin laxity around the elbows.
- Significant scarring in areas to be treated.
- Significant open wounds or lesions in the area to be treated
Sites / Locations
- New York Cosmetic, Skin and Laser Surgery Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultherapy treatment on the elbows
Arm Description
All enrolled subjects will receive one Ultherapy treatment to the elbows.
Outcomes
Primary Outcome Measures
Overall improvement of skin laxity in the areas treated
Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.
Secondary Outcome Measures
Aesthetic improvement
GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01708382
Brief Title
Feasibility Study: Lifting and Tightening of the Elbows
Official Title
Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Elbow Tissue - A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
February 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
Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Detailed Description
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.
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., Ultrasound treatment for skin tightening
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultherapy treatment on the elbows
Arm Type
Experimental
Arm Description
All enrolled subjects will receive one Ultherapy treatment to the elbows.
Intervention Type
Device
Intervention Name(s)
Ulthera System Treatment
Other Intervention Name(s)
Ultherapy™
Intervention Description
Focused ultrasound energy delivered below the surface of the skin
Primary Outcome Measure Information:
Title
Overall improvement of skin laxity in the areas treated
Description
Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.
Time Frame
90 days post-treatment
Secondary Outcome Measure Information:
Title
Aesthetic improvement
Description
GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained.
Time Frame
90 and 180 days post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female, age 21 to 65 years.
Subject in good health.
Mild to moderate skin laxity on the elbows.
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up 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.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control
Exclusion Criteria:
Presence of an active systemic or local skin disease that may affect wound healing.
Excessive subcutaneous fat around the elbows.
Excessive skin laxity around the elbows.
Significant scarring in areas to be treated.
Significant open wounds or lesions in the area to be treated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron K Rokhsar, MD
Organizational Affiliation
New York Cosmetic, Skin, and Laser Surgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Cosmetic, Skin and Laser Surgery Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study: Lifting and Tightening of the Elbows
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