Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.
This is a prospective single center study. Subjects will be enrolled one per group as they present. Efficacy will be determined by the change in submental volume and cervicomental angle. GAIS and patient satisfaction questionnaires will also be obtained.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Focused ultrasound energy delivered below the surface of the skin
DeNova Research
Chicago, Illinois, United States
Change in submental volume
Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.
Time frame: 90 days post-treatment
Overall improvement of the submental area
Global Aesthetic Improvement Scale (GAIS) and patient satisfaction questionnaires will be obtained.
Time frame: 90 days post-treatment
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