This is a prospective, controlled, multi-center study. Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the flank (love handle) area.
Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. A maximum of 55 subjects will be enrolled at up to 6 study centers. Subjects will receive up to 5 treatments with the TempSure® Firm on one flank. The other flank will be left untreated to serve a control. Subject will be required to return for follow-up visits at 6 weeks and at 12 weeks after the subject's final treatment. All subjects will receive a phone call 1 week (1-10 days) post each treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Non-invasive radiofrequency treatments
Maryland Dermatology Laser, Skin, & Vein Institute, LLC.
Hunt Valley, Maryland, United States
JUVA Skin & Laser Center
New York, New York, United States
Jeremy A Brauer MD PC
Rye, New York, United States
Saluja Cosmetic and Laser Center
Huntersville, North Carolina, United States
% of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline
Correct identification of pre-treatment images vs. the 12-week follow up images by blinded evaluators.
Time frame: 12 Week Follow Up
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Dermatology Associates of Plymouth Meeting, P.C.
Plymouth Meeting, Pennsylvania, United States
McDaniel Institute of Anti-Aging Research
Virginia Beach, Virginia, United States