Back to resultsFeasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue
Primary Purpose
Skin Laxity, Skin Crepiness
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, aged 25 to 60 years.
- Subject in good health.
- Skin laxity in the abdomen
- 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.
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the abdomen.
- Excessive skin laxity on the abdomen.
- Significant scarring in areas to be treated.
- Open wounds or lesions in the area to be treated.
- Inability to understand the protocol or to give informed consent.
- BMI equal to and greater than 30.
Sites / Locations
- Sasaki Advanced Aesthetic Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study treatment
Arm Description
All enrolled subjects will receive one Ulthera System Treatment.
Outcomes
Primary Outcome Measures
Improvement laxity/crepiness and texture of abdominal tissue
Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline
Secondary Outcome Measures
Overall aesthetic improvement
The Global Aesthetic Improvement Scale scores will be obtained from the investigator and subject, comparing post-treatment photos to pre-treatment photos.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01708499
Brief Title
Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue
Official Title
Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 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
Enrolled subjects will receive one UltherapyTM treatment on the abdomen. 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 for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, 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, Skin Crepiness
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
Outcomes Assessor
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study treatment
Arm Type
Experimental
Arm Description
All enrolled subjects will receive one Ulthera System Treatment.
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
Improvement laxity/crepiness and texture of abdominal tissue
Description
Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline
Time Frame
90 days post-treatment
Secondary Outcome Measure Information:
Title
Overall aesthetic improvement
Description
The Global Aesthetic Improvement Scale scores will be obtained from the investigator and subject, comparing post-treatment photos to pre-treatment photos.
Time Frame
180 days post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female, aged 25 to 60 years.
Subject in good health.
Skin laxity in the abdomen
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.
Exclusion Criteria:
Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat in the abdomen.
Excessive skin laxity on the abdomen.
Significant scarring in areas to be treated.
Open wounds or lesions in the area to be treated.
Inability to understand the protocol or to give informed consent.
BMI equal to and greater than 30.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Sasaki, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sasaki Advanced Aesthetic Medical Center
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue
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