Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Focused ultrasound energy delivered below the surface of the skin
DeNova Research
Chicago, Illinois, United States
Improvement in lower face and neck skin laxity
Efficacy will be assessed using the 90-day images compared to baseline
Time frame: 90 days post-treatment
Cervicomental angle
Efficacy will be assessed using the 90-day images compared to baseline.
Time frame: 90 days post-treatment
Overall aesthetic improvement
Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.
Time frame: 90 days post-treatment
Patient satisfaction
Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.
Time frame: 90 days post-treatment
Pain Assessment
Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.
Time frame: Treatment visit
Patient Satisfaction
Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.
Time frame: 180 days post-treatment
Overall aesthetic improvement
Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.
Time frame: 180 days post-treatment
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