The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.
The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Cutera Research Center
Brisbane, California, United States
New Jersey Plastic Surgery
Montclair, New Jersey, United States
Nashville Center for Laser and Facial Surgery
Nashville, Tennessee, United States
Change of Thigh Circumference From Baseline
Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.
Time frame: Comparison of Baseline to 12 weeks post- final treatment
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