In August 2010, the Erchonia Corporation was granted market clearance by the U.S. Food and Drug Administration for the non-invasive body contouring device known as Zerona. This is a brand name and in and of itself conveys nothing about what it does or how it works. Zerona is the first non-invasive device to receive FDA approval for circumferential reduction of the waist, hips, and thighs.
The Zerona works by emitting a low-level energy (hence the name ‘cold laser’) that effects fat cells through a photochemical process. It generates no heat in exerting its effects and thus is both safe and painless to undergo a treatment. Zerona has been clinically proven to target fat cells causing their immediate collapse thereby significantly reducing body volume. Through a natural process of fat removal, the laser-released fat is safely removed and broken down, providing patients with a truly non-invasive procedure without side effects or downtime.
As many patients may not know, the FDA grants approval based on the completion of a placebo-controlled, randomized, double-blind, multi-site clinical investigation. Zerona performed and submitted such a study which included 67 patients. The results from the study demonstrated an average inch loss reduction of 3.65 inches across patient’s waist, hips, and thighs in as little as two weeks. This study was done without diet restrictions or specific exercise requirements.
While this study data is compelling, it almost seems too good to be true. Can one really lose that much fat and that many inches without surgery in such a short time? As a plastic surgeon, it is initially hard to believe. Since it was approved by the FDA, I decided in my Indianapolis plastic surgery practice to see if such similar results could be replicated. Seeing is believing so to speak. I wanted to know if such clinical results could be produced in a study in which the investigator had no bias or motivation to see good outcomes.
Therefore, we studied our first 10 patients who underwent a full series of Zerona body slimming treatments. These were all women who completed 6 treatments over a two or three period, with treatments spaced anywhere from one to three days apart based on their availability and schedule. These patients were completed between September and December 2010 with the average age of the women being 46 years old. (range between 31 and 62 years of age) They took a daily supplement, Curva (niacin and ginko), and drank as much water per day as they could. Otherwise, there was no dietary restriction or exercise routinues or requirements.
In our Indianapolis Zerona study, the average circumferential measurement reduction was 6.74 inches at study completion. (range 1.7 to 12.65 inches) On a patient satisfaction scale, seven (70%) were extremely satisfied and saw significant improvement, two (20%) were satisfied as they saw improvement but had hoped for more, and one (10%) saw little change or improvement and was not satisfied.
While initially a skeptic, our first Indianapolis results were better than expected. While numbers are one thing, the most important barometer of any treatment is patient satisfaction. If a patient states they are satisfied or very satisfied, then the results have met their criteria for improvement regardless of the measurement numbers. When it comes to the measurement numbers, it is important to point how what they really mean. When you have an average number of inches lost of 6.74 inches, this does not mean it comes from the waistline or from one single body area measurement. Rather it is the collective number of inches lost from a combined number of cirumcumferential measurements including the waist, hips and thighs.
What do I conclude from our own study? First, Zerona is not magic nor is it equivalent to liposuction surgery. And it does not work well for everyone. But it appears to offer a non-surgical treatment for those patients who want to see if they can avoid liposuction surgery or need some help with their own diet and exercise program. While no guarantees can be made about results, most patients do end up see some visible body changes and were happy that they had the treatments.
Dr. Barry Eppley
Indianapolis, Indiana