OCTOBER 20, 2008 -- Michael Kulick, MD (San Francisco, CA), has developed a 3D imaging validation method for quantitatively measuring changes in cellulite. Dr. Kulick, a plastic surgeon, has been named one of the key investigators involved in an IRB-approved, multi-center, prospective, randomized clinical study to investigate the efficacy of Eleme Medical's (Merrimack, NH) SmoothShapes system. He is using a validation method that is significantly more data oriented than traditional photography: He acquires images with a 3D imaging camera for assessment of volumetric changes. The validation method documents improvement in cellulite in three dimensions.
SmoothShapes uses a proprietary technology called Photomology that promises longer-lasting cellulite improvement and the appearance of tighter, smoother skin. Thermal and non-destructive, Photomology combines dynamic laser and light energy with mechanical massage and vacuum to specifically impact the tissue components responsible for the appearance of cellulite. Collagen is regenerated, circulation is improved and metabolic processes are restored, says Eleme Medical.
Using the 3D system to validate results of the study will allow new data points for documenting improvement in the appearance of cellulite. "This system is designed to provide reproducible 3D photographs and measure change in the volume between two surfaces. Therefore, if a positive change is observed after treatment, we should be able to tell what kind of volume change provided these results," explained Dr. Kulick. He adds, "The imaging process will also allow my study to track results over time."
Although the original SmoothShapes device gained FDA market clearance in July 2006, Eleme Medical pursued market preference studies at 16 test centers around the world before launching the device commercially in April of 2008.
Kulick began his study in May and will present findings at the American Society of Plastic Surgeons meeting next month (November 2-4, Chicago). More than 85 percent of women will develop cellulite at some point in their lives and it can't be controlled or eliminated through diet or exercise.