Wrinkles Clinical Trial
Official title:
Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand
Enrolled subjects will receive Ultherapy™ System treatment on the back of their both hands. Follow-up visits will occur at 90 days post-treatment. Study photos will be obtained pre-treatment and at 90 days post-treatment
Before Treatment:
The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the 5-point
Hand Grading Scale wil be evaluated by the Investigator in charge of assessment.
Treatment:
The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with
20 lines of 1.5 and 3.0 probe respectively to the back of the left and right hand .
Post-Treatment:
All subjects will visit the Institution at12 weeks from the day of procedure, and will take
photos of the back of the hands. Efficacy evaluation will performed by the Photographic
Evaluator.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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