Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.
This pilot study is a prospective, single-center clinical trial of the Ulthera® System for treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient Satisfaction questionnaires will be obtained at each follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Focused ultrasound energy delivered below the surface of the skin
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Improvement in overall lifting and tightening of knee skin laxity.
Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.
Time frame: 90 and 180 days post-treatment
Overall improvement in skin laxity.
Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire.
Time frame: 90 and 180 days post-treatment
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