Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 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, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Focused ultrasound energy delivered below the surface of the skin.
Dermatology, Cosmetic & Laser Surgery
Rockville, Maryland, United States
Improvement in facial wrinkles and lifting and tightening of skin
Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline
Time frame: 90 days post-treatment
Overall aesthetic improvement
Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.
Time frame: Participants will be followed up to 180 days post-treatment
Overall patient satisfaction
Determined based on Patient Satisfaction and Quality of Life questionnaire scores.
Time frame: 90 and 180 day post-treatment
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