Up to 40 participants will be enrolled, randomized and treated. Enrolled participants will receive one, split-face Ulthera® treatment on the face and neck using a Ulthera System standard transducer on one side of the face and a Ulthera System prototype simulines transducers on the other side of the face. 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.
This is a prospective, multi-center, split-face, randomized pilot trial to determine the clinical feasibility of the Ulthera System prototype simulines transducers, that is, transducers which deliver two lines of treatment simultaneously (at once), in comparison to the standard transducers which deliver a single treatment line, by collecting average pain scores in the treated regions, as well as efficacy and treatment efficiency data. There will be 3 study arms with each arm having 2 treatment groups. Enrolled participants will be randomized to one of two study arms, and one of two treatment groups within each study arm.to determine which side of the face will be treated with Ulthera System standard transducers and Ulthera System prototype simulines transducers and the energy level for treatment. Participants will receive one dual-depth treatment at 4.5 millimeter (mm) and 3.0mm depths. Clinical feasibility will be assessed based on comfort level of standard transducers versus simulines transducers by comparing average pain scores obtained during study treatment. Efficacy will be determined based on qualitative masked assessment of post-treatment photographs compared to pre-treatment photographs and quantitative eyebrow lift measurements. Patient satisfaction questionnaires will be obtained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
42
Focused ultrasound energy delivered below the surface of the skin.
Focused ultrasound energy delivered below the surface of the skin.
Clinical Testing of Beverly Hills
Beverly Hills, California, United States
California Skin Institute - Saratoga
Saratoga, California, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Comfort level of standard transducers versus simulines transducers during Ultherapy® treatment
Subjects' treatment-related pain scores will be obtained using a validated 0-10 point Numeric Rating Scale while study treatment is being administered. It is estimated that each study treatment will be completed in approximately 90 minutes.
Time frame: During study treatment. Participants will be followed for an average of 90 minutes.
Brow lift obtained using simulines versus standard transducers
Brow lift as assessed by quantitative measurements of pre- to post-treatment photos.
Time frame: 90 days post-treatment
Brow lift obtained using simulines versus standard transducers
Brow lift as assessed by quantitative measurements of pre- to post-treatment photos.
Time frame: 180 days post-treatment
Improvement in overall lifting and tightening of skin
As assessed by a masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.
Time frame: 90 days post-treatment
Improvement in overall lifting and tightening of skin
As assessed by a masked, qualitative assessment of photographs at 180 days post-treatment compared to baseline.
Time frame: 180 days post-treatment
Patient Satisfaction
As assessed by a patient satisfaction questionnaire completed by the subject.
Time frame: 90 days post-treatment
Efficiency of simulines versus standard transducers
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As determined by comparing treatment times using the simulines transducers compared to treatment times using the standard transducers.
Time frame: During study treatment