Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ulthera, Inc
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Improvement laxity/crepiness and texture of abdominal tissue
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Study treatment
All enrolled subjects will receive one Ulthera System Treatment.
Intervention: Ulthera System Treatment (Device)
Outcomes
Primary Outcomes
Improvement laxity/crepiness and texture of abdominal tissue
Time Frame: 90 days post-treatment
Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline
Secondary Outcomes
- Overall aesthetic improvement(180 days post-treatment)