Noninvasive subcutaneous fat removal is quite possibly the final frontier of elective cosmetic surgery, and, according to Los Angeles cosmetic surgeon Paul Nassif, M.D., a low level laser therapy (LLLT) that has already successfully undergone a phase 1, double-blind, placebo-controlled Food and Drug Administration (FDA) clinical trial may hold the key to cannula-free body contouring.
Erchonia Medical, manufacturer of the Zerona cold diode laser, submitted to the FDA a placebo-controlled, randomized, double-blind, multicenter study of 67 subjects treated with the Zerona for body slimming. The trial assessed the placebo effect and did not advocate any dietary or lifestyle modifications. Patients received treatment every other day for two weeks for a total of six treatments. Thirty-five received "true" laser stimulation and 32 received "sham" laser stimulation. The mean change in the total combined circumferential measurements from baseline to endpoint was a loss of 3.5 inches for the treated group and loss of 0.68 inches for the placebo group.
A LARGER LOOK A much larger, albeit non-randomized, non-controlled study for which Dr. Nassif is an investigator also offers noteworthy outcomes. Dr. Nassif represents one of 50 U.S. private practices that have provided data on 567 patients receiving LLLT for body slimming with the Zerona cold laser.As an investigator in the retrospective study, Dr. Nassif recently reported his findings at a national meeting. He says the procedure is best-suited to candidates who have a body mass index (BMI) between 20 and 30, and whose aim is to reduce deposits of subcutaneous fat.
In the national, multicenter study designed to demonstrate the efficacy of LLLT for circumferential body reduction, the average age for female patients was 47 and male patients averaged age 51. The average reduction in treated areas, represented by a mean loss, was a total of 4.2 inches for each patient, with a breakdown of 1.5 inches off the waist; 1.2 inches off the hips; 0.8 inches off the right thigh; and 0.7 inches off the left thigh. Of the entire cohort, 76.1 percent exhibited a total reduction of at least 3 inches or greater in two weeks; for the remaining percentage of patients, a majority reported a total average circumferential reduction of 2.2 inches, with 8 percent experiencing an average reduction of 0.9 inches. Collectively, 96.8 percent experienced a circumferential measurement reduction across their waist, hips and bilateral thighs. Of the entire group, 65.1 percent demonstrated a circumferential loss of at least 2.5 or more inches in two weeks across the waist, hips and thighs.
EVIDENCE AND CRITICISM Dr. Nassif points out that while evidence of its efficacy is mounting, cold laser lipolysis has yet to prove itself to the cosmetic surgery community at large. Some critics of the technology have suggested that the mechanism of action is probably a redistribution of fluids. Ryan Maloney, Ph.D., of Erchonia Medical's research and development team, says this is unlikely, because clinical trial data has shown that the circumferential reduction was maintained for two weeks after treatment.
Measurements were also taken at systemic points (neck, arm, knee) that were not treated. Interestingly, the non-treated areas also demonstrated a mean reduction of approximately 3.6 inches per person, pushing the total mean reduction per patient to 7.7 inches over the two-week treatment period. Theoretically, if a redistribution of fluids was responsible for the reduction in the treated areas, the non-treated areas would demonstrate a gain in inches.
The Zerona cold laser has a unique effect on fat cells, according to Dr. Nassif. When the cell absorbs the low level laser light of 635 nm, an opening, or "pore," forms within the cell's protective barrier. Creating an opening in this structure provides a means for the stored material, or fat, to be released. Fat stored within each cell represents 6 percent of cell weight but can represent as much as a 1,000-fold increase in volume, according to Dr. Maloney. Therefore, the removal of fat from the cell does not impact weight fluctuation, but it does contribute to a significant reduction in inches.