Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. Follow-up visits will occur at 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, double-blinded, split-face, randomized pilot study. A triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. Changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. Patient satisfaction questionnaires will also be obtained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Focused ultrasound energy delivered below the surface of the skin
Radiofrequency treatment focusing radiofrequency energy
FACES+
San Diego, California, United States
Number of Participants with Lifting and Tightening of Skin
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system.
Time frame: 180 days post treatment
Number of Participants with Wrinkle Reduction
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system
Time frame: 180 days post treatment
Number of Participants with Eyebrow Lift
Quantitative measurements of eyebrow lift will be obtained at follow-up compared to baseline.
Time frame: 90 days post-treatment
Number of Participants with Lower face and Neck Lift
Quantitative measurements of lower face and neck lift will be obtained at follow-up compared to baseline.
Time frame: 90 days post-treatment
Number of Participants Reporting Treatment Satisfaction
Subjects will complete a split-face Patient Satisfaction Questionnaire at 180 days following study treatments.
Time frame: 180 days post-treatment
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