RESEARCH UPDATE

Based on their commitment to evidence-based medicine, a ZERONA® Canada provider has been selected to participate in a Food and Drug Administration (FDA) study, evaluating the efficacy of laser therapy for subcutaneous fat reduction in obese and morbidly obese patients. Having received ethical board approval today to participate as a site for this international study, they are now able to commence the trial. The participation of Zerona Canada providers in trials like these reinforces the promise to improve the quality of care clients, like you, receive.

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Zerona, Mechanism of action

The exact mechanism of action for the Zerona is not fully understood. As a low-level laser device, the theory of action is defined as bioorganic photochemistry, a discipline that explores the interaction between photons and biochemical pathways within cells. Like many other science principles, bioorganic photochemistry is defined by laws, and the first law of photochemistry states that a photoabsorbing structure must be present to yield a clinical outcome. Cytochrome c oxidase, a terminal enzyme found within the electron transport chain of the mitochondria, has been reported to function as a photoabsorbing complex within eukaryotic cells (eukaryote). This enzyme is responsible for facilitating the transport of electrons across the inner mitochondrial membrane to reduce oxygen and generate a proton electrochemical gradient. Cytochrome c oxidase serves an important role in the metabolic process known as oxidative phosphorylation, which is the production of the high energy molecule adenosine triphosphate (ATP). Stimulation of cytochrome c oxidase with a well-defined monochromatic low-level laser instrument modulates cellular metabolism and secondary biological cascades that can affect cell function and behavior, giving rise to the positive clinical outcomes that have been reported. Subsequent to laser stimulation, the mitochondrial membrane potential and proton gradient increases, prompting changes in mitochondria optical properties and increasing the rate of ADP/ATP exchange. It is suggested that laser irradiation increases the rate at which cytochrome c oxidase transfers electrons from cytochrome c to dioxygen. Moreover, it has been proposed that laser irradiation reduces the catalytic center of cytochrome c oxidase, making more electrons available for the reduction of dioxygen. In turn, an increase in electron and proton transfer increases the quantity of ATP that is synthesized, which can directly affect numerous intracellular proteins.

The upregulation of ATP induced by laser therapy is also responsible for the increased production of a natural byproduct known as reactive oxygen species (ROS). This highly reactive oxygen molecule participates in numerous pathways within a cell. However, as the concentration of ROS elevates, a process known as lipid peroxidation can occur where ROS reacts with lipids found within cell membranes temporarily damaging them. It has been hypothesized that the Zerona, as a low-level laser device, modulates cell metabolism resulting in a transient rise of ROS, which temporarily degrades the membrane, creating transitory pores or openings. Presently, studies are on-going to fully elucidate the underlying mechanism of action.

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Zerona – Device

Zerona is a class II low-level laser under 21 CFR 878.540. Low level laser therapy(LLLT) represents a division of photomedicine utilizing defined parameters of laser light for the treatment of a specific medical ailment. The efficacy and safety of this therapeutic approach is dependent on the wavelength, dosage, pulsation, and intensity being applied. For instance, laser therapy has exhibited a biphasic dose response revealing that too much applied energy could hamper or prevent the desired clinical outcome from transpiring. The development of Zerona required significant clinical investigation to determine the ideal output parameters to ensure optimal efficacy and safety. Studies evaluated Zerona’s interaction with individuals to several million fat cells in order to determine the precise slimming setting. Zerona is a monochromatic semiconductor diode laser that emits 5 independent 635 nm divergent beams.

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Realistic Look at Noninvasive Body Contouring

As popular as noninvasive body contouring is, current technologies come with realistic expectations and limitations. Pregnant patients or those who have a pacemaker, a substantial BMI or other medical problems are not good candidates for the procedures.

Those who are must be realistic about their expectations. These may include a modest reduction in localized fat and possibly some improvement in cellulite. These patients have to realize that they will need multiple visits to accomplish their goals, and that as yet, the results will not be as effective as surgery. In addition, they have to have a lifestyle and BMI conducive to maintaining whatever results do occur.

Pros and cons of the various methods

  • For nearly two decades, endermology has been available. This suction/massage device from France uses a mechanical apparatus that rolls over body areas with fat and/or cellulite. Mainly used in day spas, this technique involves several half-hour treatments and modest effectiveness.
  • A major player in the body-contouring market is the radiofrequency (RF) energy device. Among these are VelaSmooth and VelaShape. These involve infrared light and thermal energy applied to the skin with manual manipulation. Their use minimizes the amount of energy needed to the skin and can be used for all skin types.
  •   Monopolar RF devices include Thermage™ and Accent. They do not involve suction coupling or adjunctive optical energy sources.
  • TiteFX involves the use of suction-coupled RF to preheat the skin and top layer of fat, monitors the temperature and distribution of the suction, and at a certain temperature delivers a high-voltage pulse through the adipose tissue. The fat cells die over the proceeding few days. This method results in less pain, fewer hot spots and longer-term improvements.
  • HIFU is an acronym for high-frequency noninvasive ultrasound. Body-contouring in this way can also cause the death of fat cells rather than just affecting their metabolism, and thus offer longer-term results. There are many of these devices on the market, UltraShape and LipoSonix among them. They are awaiting FDA clearance.
  • Zerona offers low-level laser therapy (LLLT) that does not immediately raise the temperature of the tissue being treated. This method has been used as helpful addition to many cosmetic procedures such as breast augmentation and liposuction. It has also gained credence on its own as an effective way to reduce the size of the waist, thighs and hips. The result of intensive research, Zerona does not destroy the cell membrane, but creates a temporary pore through which the fat can emerge. Many studies have supported the concept that light can penetrate the skin and create photochemical responses from tissue. As the only generalized laser-slimming technique in the noninvasive body-contouring world, Zerona provides appropriately selected patients with slimming results with less inflammation and without the death of cells.

Some of the noninvasive body-contouring methods can be used to treat cellulite, which is still relatively misunderstood. These include RF devices and LLLT. As long as safety protocols are followed, complications are rare in any of the noninvasive body-contouring techniques – except for unrealistic patient expectations for the results. They are most appropriate for carefully selected patients who do not consider surgery a viable option, and who understand the limitations of what noninvasive body-contouring can achieve.

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Noninvasive Body Contouring

Change is a constant in today’s world. As people’s attitudes toward health and self-image evolve, so do medical practices that address their interests and concerns. One example is esthetic surgery, which is undergoing a swing from traditional options to noninvasive body contouring. Patients have driven this change with demands for safer procedures that avoid the negative consequences of current surgical practices. They wish to avoid hospitalizations, pain, anesthetics, swelling and long recovery times.

We are even seeing this metamorphosis occurring in standard surgical lipectomy techniques. Liposuction was introduced in the late 1970s, and today is the most common surgery performed by esthetic plastic surgeons in North America. The field has changed a lot. Over the decades, power-assisted liposuction morphed to ultrasound or laser-assisted methods, and then radio-frequency (RF) modalities. The benefits range from better results to a shorter recovery period, less intensive bruising and increased skin tightening.

Patients wishing to lose fat quickly are championing noninvasive methods for lipolysis – and this market is alarmingly substantial. The body mass index (BMI) and average weight of North Americans is increasing, and obesity has reached epidemic proportions. Suction-assisted lipolysis (SAL) is still largely used. The benefits of nonexcisional body-contouring methods, however, may result in less swelling, pain and skin discoloration from ruptured blood vessels, as well as better skin contraction. These include third-generation ultrasound (UAL), laser-assisted lipolysis (LAL), and RF-assisted liposuction (RFAL).

The science of this revolves around the adipocyte. Found in connective tissue, this cell has the special job of storing fat in the form of triglycerides, which contain free fatty acids and glycerol. Adipocytes swell and form bulges when caloric intake exceeds caloric expenditure. Most commonly, those seeking body contouring choose to have fat pouches such as these removed through liposuction. Certainly less invasive than it was in its beginning, liposuction still requires surgery that brings with it risk – and as a result, many people who might otherwise consider body contouring in some form shy away from it. They are seeking noninvasive techniques.

The demand for noninvasive body-contouring has made it the fastest growth market segment in esthetic medicine. Numerous noninvasive body-contouring procedures are now available in North America. These procedures differ by the way they accomplish the goal. Some involve emit energy that damages the adipocyte membrane or in some other way releasing the contents of the cell. Others call on low-level light laser therapy, which allow for temporary release of triglycerides from the cell with the membrane reforming itself. When either happens over millions of fat cells, the result is a reduction of fat in the area. Low-level light laser therapy devices by Zerona are examples of the latter.

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Mechanisms of Low Level Light Therapy (LLLT) – Clinical Studies

Medical Report – 2010

Low-power laser therapy is used by physical therapists to treat a wide variety of acute and chronic musculoskeletal aches and pains, by dentists to treat inflamed oral tissues and to heal diverse ulcerations, by dermatologists to treat edema, non-healing ulcers, burns, and dermatitis, by orthopedists to relieve pain and treat chronic inflammations and autoimmune diseases, and by other specialists, as well as general practitioners. Laser therapy is also widely used in veterinary medicine (especially in racehorse-training centers), and in sports-medicine and rehabilitation clinics (to reduce swelling and hematoma, relieve pain, improve mobility, and treat acute soft-tissue injuries). Lasers and LEDs are applied directly to the respective areas (e.g., wounds, sites of injuries) or to various points on the body (acupuncture points, muscle trigger points). However, one of the most important limitations to advancing the LLLT field into mainstream medical practice is the lack of appropriately controlled and blind clinical trials. The trials should be prospective, placebo controlled, and double blinded, and contain sufficient subjects to allow statistically valid conclusions to be reached.

Clinical applications of low-power laser therapy are diverse. The field is characterized by a variety of methodologies, and uses of various light sources (lasers, LEDs) with different parameters (wavelength, output power, continuous-wave or pulsed operation modes, and pulse parameters).

In recent years, longer wavelengths (~800 to 900 nm) and higher output powers (to 100 mW) have been preferred in therapeutic devices, especially to allow deeper tissue penetration. In 2002, MicroLight Corp received 510K FDA clearance for the ML 830 nm diode laser for the treatment of carpal tunnel syndrome. There were several controlled trials reporting significant improvement in pain, and some improvement in objective outcome measures. Since then several light sources have been approved as equivalent to an infrared heating lamp for treating a wide-range of musculoskeletal disorders with no supporting clinical studies.

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Reduction in serum Low-density lipoprotein levels following low-level laser therapy

The application of low-level laser therapy has been recognized as a viable means to treat a wide-assortment of medical conditions and disorders. Numerous studies have revealed the adaptability capabilities of laser therapy at the cellular level, impacting transcription (the copying of DNA into messenger RNA) and gene expression. Low-density lipoproteins (LDL’s), when elevated, have been identified as a direct contributor to the onset of cardiovascular disease. With a significant percentage of LDL produced in the body via specific transcription activated biochemical pathways, LLLT may have the potential to impact cholesterologenesis.

A study was conducted to evaluate the efficacy of laser therapy in the reduction of LDL’s. The conclusion of the study was, given that a change in LDL from baseline to study end point evaluation is considered both statistically significant and clinically meaningful if it is a 15% or greater decrease, that the data suggests that laser therapy may serve as a subtle, non-invasive instrument for the reduction of LDL levels in just two weeks.

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Low-Level Laser Therapy as a Non-Invasive Approach for Body Contouring

Transmission electron microscopic images have demonstrated the formation of transitory pores in adipocyte cell membranes (fat cells, are the cells that primarily compose adipose tissue, specialized in storing energy as fat) followed by the collapse of adipose cells subsequent to laser irradiation of 635 nm. The objective is to evaluate the application of a 635 nm and 17.5 mW exit power per multiple diode lasers for the application of non-invasive body contouring of the waist, hips, and thighs.

Study Design/Patients and Methods: Double-blind, randomized, placebo-controlled trial of a 2-week non-invasive laser treatment conducted from May 2007 to June 2008 across multiple-private practice sites in the United States of America. Sixty-seven volunteers between the ages
of 18–65 with a body mass index (BMI) between 25 and 30 kg/m 2 and who satisfied the set inclusion criteria participated. Eight of the 67 subjects did not have circumference measurements recorded at the 2-week post-procedure measurement point. Participants were randomly assigned to receive low-level laser treatments or a matching sham treatment three times per week for 2 weeks.
Reduction in the total combined inches of circumference measurements of the waist, hip and bilateral thighs from baseline to the completion of the 2-week procedure administration phase was assessed.

Participants in the treatment group demonstrated an overall reduction in total circumference across all three sites of 3.51 in. (P < 0.001) compared with control subjects who revealed a 0.684 reduction (P < 0.071745). Test group participants demonstrated a reduction of 0.98 in (P < 0.0001) across the waist, 1.05in (P < 0.01) across the hip, and 0.85in (P < 0.01) and 0.65in (P < 0.01) across the right and left thighs from baseline to 2 weeks (end of treatment). At 2 weeks post-procedure, test group subjects demonstrated a gain of 0.31 total inches collectively across all three sites. These data suggest that low-level laser therapy can reduce overall circumference measurements of specifically treated regions.

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Low-Density Lipoproteins (LDL)

The application low-level laser therapy, like the one used in Zerona, has been recognized as a viable means to treat a wide-assorted of medical conditions and disorders. Numerous studies have revealed the modulatory capabilities of laser therapy at the cellular level, impacting transcription factor (the protein that binds to specific DNA sequences) and gene expression (the process by which information from a gene is used in the synthesis of a functional gene product. These products are often proteins).
Low-density lipoproteins (LDL’s), when elevated, have been identified as a direct contributor to the onset of cardiovascular disease. With a significant percentage of LDL produced in the body via specific transcription activated biochemical pathways, LLLT may have the potential to impact cholesterologenesis. The objective of this study was to evaluate the efficacy of laser therapy in the reduction of LDL’s.
Based on the FDA Guidance Document: Guidelines for the Clinical Evaluation of Lipid-Altering Agents in Adults and Children, September 1990, Division of Metabolic and Endocrine Drug Products, Food and Drug Administration, a change in LDL from baseline to study and point evaluations is considered both statistically significant and clinically meaningful if it is a 15% or greater decrease. This suggests that the laser therapy may serve as a subtle, non-invasive instrument for the reduction of LDL levels in just two weeks.

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Zerona Treatment Procedure

Each Zerona session takes less than an hour; the low-level laser is used for a total of 40 minutes. The laser is applied to the targeted area, which is generally a combination of the waist, hips, and thighs, for 20 minutes. The patient then turns over and the very same treatment is applied to the opposite side. The minimum suggested treatment period is two weeks, with three full sessions each week. You should consult your physician about the maximum results for your body type, weight, and target loss.

Many patients have described the session as relaxing, and even Zen. Some even try to catch up on phone calls with friends and loved ones as they lay down. You simply lay in a comfortable, stationary position for twenty minutes at a time, in a relaxed environment, while the cold laser does all of the work. Since the Zerona uses cold laser technology, you feel nothing during the procedure. You may feel a bit different and lighter as you exit the treatment center due to the bio-stimulation that begins in your body.

Zerona treatment liquifies the fat and the cell dumps it into the intracellular space. There are two types of fat cells – Subcutaneous and Visceral. Subcutaneous fat is located directly above the skeletal muscle and below the skin. Its superficial placement is what ensures proper depth penetration of the laser energy. Patients containing a high volume of visceral fat (fat below the skeletal muscle) are not ideal candidates for this procedure. However, they may still contain subcutaneous fat; therefore, you can treat the individual by just ensuring they adopt a healthy diet to address the visceral fat.

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