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Noninvasive lipolysis demand fueled by desire for more modest results

Article-Noninvasive lipolysis demand fueled by desire for more modest results

Key iconKey Points

  • Approved methods for noninvasive lipolysis include low-level 635 nm diode laser, cryolipolysis and radiofrequency devices
  • Noninvasive ultrasonic lipolysis may become available in 2011, as two investigational devices are undergoing FDA review

Is industry responds to consumer interest in noninvasive cosmetic procedures, several modalities for noninvasive fat removal have been introduced — and more are on the horizon.

Dr. Butterwick
However, data from well-designed, controlled studies are needed to better determine how well these methods work and the longevity of their results, says Kimberly J. Butterwick, M.D., who spoke at the 69th annual meeting of the American Academy of Dermatology in February.

"Liposuction may be one of the most popular invasive cosmetic procedures, but it only represents the tip of the iceberg compared to the market opportunity for noninvasive body contouring," says Dr. Butterwick, a dermatologist and cosmetic surgeon in private practice in San Diego.

"Available evidence suggests the marketed and investigational techniques usually produce modest reductions in body circumference at best, and so they are clearly not a replacement for liposuction, and while safety seems acceptable with most methods when used appropriately, there are potential concerns," she says. "With more information on outcomes of noninvasive lipolysis needed and research and technology rapidly evolving, physicians interested in offering these procedures might be cautious about jumping on the bandwagon too soon."

Consumer interest is high, however, and devices that are easy and safe, and will help patients lose even 1 inch, will be popular.

Currently, approved methods for noninvasive lipolysis include use of a low-level, 635 nm diode laser (Zerona, Erchonia), cryolipolysis (CoolSculpting, Zeltiq) and radiofrequency devices. Mesotherapy and focused external ultrasound platforms are awaiting approval from the Food and Drug Administration (FDA).

MARKET CHOICES A published, uncontrolled study evaluating the 635 nm diode laser (Jackson RF, Dedo DD, Roche GC, et al. Lasers Surg Med. 2009;41(10):799-809) reported that patients achieved an average reduction of slightly more than 5 inches circumference over the waist, hips and thighs after two weeks. The device has been met with skepticism, however.

"Because the adipocyte cells are not destroyed, the results are probably temporary," Dr. Butterwick says.

A patient with "love handles" before (left) and one month after one cryolipolysis treatment with Zeltiq's CoolSculpting system. There was no reported change in the patient's weight between the taking of the before and after images. (Photo credit: William F. Groff, M.D.)
Radiofrequency devices for noninvasive lipolysis feature monopolar energy modes that sufficiently penetrate to reach fat. Published data from studies using a combination bipolar and unipolar radiofrequency device (Accent, Alma Lasers) show contraction of approximately 20 percent fat volume (Rosado RH, del Pino EM, Azuela A, et al. J Drugs Dermatol. 2006;5(8):714-722). Dr. Butterwick says she has found that off-label treatment with the unipolar ThermaCool (Solta Medical) unit can reduce a thin layer of fat, but the procedure can be very painful, especially when used on the upper arms.

Equipped with an adjustable cooling tip, another proprietary monopolar radiofrequency platform (Exilis, BTL Industries) reaches multiple levels of fat, but still only achieves up to 2.5 cm penetration into the adipose layer, Dr. Butterwick says. The treatment uses no disposables, and in clinical use, the procedure appears to be more comfortable for patients compared to other monopolar radiofrequency devices.

"However, a course of treatment involves four shorter weekly sessions instead of one longer procedure, and burns are still a risk, as with any radiofrequency treatment," Dr. Butterwick says.

Another commercially available platform for noninvasive body contouring is based on cryolipolysis (CoolSculpting, Zeltiq) that selectively cools fat cells without causing injury to other tissue. Histological evidence from a study conducted in a porcine model shows that the cooling induces apoptosis and an inflammatory reaction resulting in clearance of the dead fat cells by phagocytosis (Zelickson B, Egbert BM, Preciado J, et al. Dermatol Surg. 2009;35(10):1462-1470). An unpublished clinical study by Geronemus et al using ultrasound imaging before and after one session in 10 patients showed the process resulted in about a 25 percent reduction in fat layer thickness after four months.

The device features large and small clamp-like applicators that hold the patient's tissue with a vacuum. The procedure takes about an hour, but an operator need not be present. Post-treatment sequelae include redness and sensitivity that may last for several hours and bruising, soreness, cramping and tenderness that may be present for a few days. There are some rare reports (less than 1 percent) of moderate to severe paresthesia-related pain persisting for several weeks, Dr. Butterwick says.

"Before and after photos indicate that cryolipolysis can result in visible reduction in fat bulges, but the other side of the coin is that some patients — perhaps up to 30 percent, based on anecdotal reports — are disappointed with the outcome," she says.

Dr. Butterwick says the results achieved may depend on how well the targeted area is drawn into the applicator, which may be limited at certain anatomic sites or if the fat deposit is too small. In addition, longer follow-up is needed to determine the duration of the result achieved and whether there are contour irregularities between the treated and untreated sites.

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