The purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks.
VelaShape is a non-invasive (not breaking the skin) device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation. The CoolSculpt System is a noninvasive device that reduces fat by freezing fat cells until they break apart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
Subjects will receive one treatment to their entire waist / love-handle/ flanks area in a split-waist fashion, so that one side is treated with one device and the other side is treated with the other device. The treatment session will include: one side (right or left) treated with the VelaShape III device and the other side (left or right, respectively) with the CoolSculpt device. The subject will be randomized to one of 2 treatment groups, one will receive treatment to the left side with the VelaShape II and the right side will receive treatment with the CoolSculpt. The other group will receive treatment to right side with the VelaShape II and the left side will receive treatment with the CoolSculpt.
Noninvasive Cryolipolysis
Coleman Center for Cosmetic Dermatologic Surgery
Metairie, Louisiana, United States
A blinded rating of the treatment area
Improvement scores of photographs for the treatment side with the VelaShape III device versus the side treated with CoolSculpt will be blindly evaluated by independent reviewer at baseline and at 3 month post treatment time-point.
Time frame: 3 month post treatment
A blinded rating of the treatment area
Improvement scores of photographs for the treatment side with the VelaShape III device versus the side treated with CoolSculpt will be blindly evaluated by independent reviewer at baseline and at 1 week, 1 month and 6 months post treatment time-point.
Time frame: 1 week, 1 month and 6 months post treatment
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