Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatment Approach
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ulthera, Inc
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Improvement in overall lifting and tightening of the skin
Study Overview
Brief Summary
All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.
Detailed Description
This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores 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 area(s) to be treated.
- •Understands and accepts the obligation not to undergo any other procedures in the area(s) 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 area(s) to be treated.
- •Excessive skin laxity on the area(s) to be treated.
- •Significant scarring in area(s) to be treated.
- •Open wounds or lesions in the area(s) to be treated.
- •Severe or cystic acne on the area(s) to be treated.
- •Presence of a metal stent or implant in the area(s) to be treated.
- •Inability to understand the protocol or to give informed consent.
- •BMI equal to and greater than 30.
Arms & Interventions
Ultherapy™ study treatment
Each subject will receive a customized, high-density, vectored Ulthera System Treatment.
Intervention: Ulthera System Treatment (Device)
Outcomes
Primary Outcomes
Improvement in overall lifting and tightening of the skin
Time Frame: 90 days post-treatment
As determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline. The clinical response of Ulthera treatment will be assessed by comparing photographic images taken before and after the procedure.
Secondary Outcomes
- Overall aesthetic improvement(365 days post-treatment)