This is prospective, multi-center, single-blinded, non-randomized clinical trial. Enrolled subjects will receive two Ulthera® treatments on the peri-orbital and peri-oral regions, each treatment provided 30 days apart. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Focused ultrasound energy delivered below the surface of the skin
Center for Advanced Facial Plastic Surgery
Beverly Hills, California, United States
Aesthetic Plastic Surgical Institute
Laguna Beach, California, United States
About Skin Dermatology and DermSurgery, PC
Englewood, Colorado, United States
Dermatology Research Institute
Coral Gables, Florida, United States
Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2.
Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 90 days post-treatment #2.
Time frame: Participants will be followed to 90 days post-treatment #2
Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 180 days Post Treatment #2.
Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 180 days post-treatment #2.
Time frame: Participants will be followed to 180 days post-treatment #2
Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 90 days post treatment #2.
Quantitative wrinkle depth measurements will be performed using a 3-D imaging system at 90 days post-treatment #2.
Time frame: Participants will be followed to 90 days post-treatment #2
Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 180 days Post Treatment #2.
Quantitative wrinkle depth measurements will be performed using a 3-D imaging system at 180 days post-treatment #2.
Time frame: Participants will be followed to 180 days post-treatment #2
Overall Aesthetic Improvement
Overall aesthetic improvement at 90 days post treatment #2 compared to baseline will be assessed using the Global Aesthetic Improvement Scale (GAIS).
Time frame: Participants will be followed to 90 days post-treatment #2
Overall Aesthetic Improvement
Overall aesthetic improvement at 180 days post treatment #2 compared to baseline will be assessed using the Global Aesthetic Improvement Scale (GAIS).
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Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, United States
Time frame: Participants will be followed to 180 days post-treatment #2
Subject Satisfaction
Subject satisfaction will be measured at using a Patient Satisfaction Questionnaire.
Time frame: Participants will be followed to 90 days post-treatment #2