Chromogenex, the creators of i-Lipo, are delighted to receive FDA clearance to market the successful i-Lipo low level laser diode device for circumference reduction of the waist. The i-Lipo is the first direct skin contact laser device for fat reduction and body contouring to receive such approval for circumference reduction. Results from a recent double-blind, placebo controlled randomized study of 34 volunteers were scrutinized by the FDA; the measurement data and patient satisfaction evaluation of treatment outcome validating the use of the i-Lipo to specifically target chosen anatomical areas for fat reduction.
Of the 34 male and female participants recruited onto the study, 19 were randomized into the treatment group and 15 into the control group. The treatment group received 8 20-minute laser treatment sessions, scheduled over a 3-4 week period, each of which were followed by a period of post-treatment exercise. The control group undertook an identical scheduling and exercise program, but using a sham light diode device. Participants were unaware of their group allocations until after the end of the study.
The individual success criteria for the study participants was to achieve a minimum reduction of 4.0cm (1.5 inches) from the circumference measurement of the waist from baseline following the course of 8 i-Lipo treatments. 79% (15 of 19 participants) of the test group achieved and surpassed this reduction, while only 6.7% (1 participant out of 15) of the control group achieved the target. This 72% difference between the two groups is more than double the % difference defined by the FDA as demonstrating a significant result from treatment. Comparison of the test group and control group mean circumference reduction from baseline measurements to the end of the treatment phase demonstrated a mean difference of -3.8cm between the two groups. This result is extremely statistically significant and gives a confidence of >99.99% that a participant undertaking i-Lipo will achieve a greater circumference reduction than a participant undertaking exercise alone in a 3-4 week period.
This study supports previous study data completed in France and the UK and from the current i-Lipo devices already placed in over 1000 commercial clinics worldwide.