Ultrasound rejuvenation promises skin tightening and body contouring. Too good to be true?

In 2009, FDA approved an ultrasound device Ultera (The Ultera Ultrasound System) designed for skin tightening treatments of face and neck. Unfortunately, the FDA approval standards for medical devices are less demanding than those for drugs, especially as far as effectiveness is concerned. Hence FDA approval alone is insufficient to validate the promise of "ultrasonic facelift".

Clinical studies of ultrasound facial rejuvenation are few and the independent ones are even fewer.

A pilot 2007 study by Dr Gliklich and colleagues at Harvard Medical School evaluated the safety of ultrasound applied to facial skin for cosmetic purposes. The researchers treated fifteen subjects and found that the procedure was safe and well-tolerated and produced "targeted, precise, and consistent thermal injury zones in the dermis and subcutaneous tissues with sparing of the epidermis". In other words, the treatment produced the intended, precisely controlled, therapeutic lesions without any significant "collateral" damage. However, the study did not evaluate whether the treatment resulted in skin tightening or other beneficial changes.

In a 2010 study conducted at Feinberg School of Medicine, Northwestern University, Dr Alam and co-workers evaluated the efficacy of ultrasound skin tightening for brow-lift in the context of a procedure treating the full face and neck. The study involved 36 subjects and was designed as a rater-blinded prospective cohort study. In other words, the people who rated the results didn't know whether the results came from the treated subjects or controls. On the other hand, the subjects did know that they were being treated by a real device rather than a sham. (This is not an ideal but reasonably good design for this kind of study.) Eighty six percent of the subjects were judged by raters to show clinically significant brow-lift 90 days after treatment. The average change in eyebrow height as assessed by measurement of photographs at 90 days was 1.7 mm. The side effects were reported to be minimal and included transitory mild erythema (redness) and edema. I should note that this study has been funded by the manufacturer of Ultera.

A lot more studies (especially independently funded ones) are needed to definitively determine whether ultrasound has clear advantages over other noninvasive skin tightening procedures. In the meantime, Ultera face and neck lifts (dubbed Ultherapy) are becoming available in a growing number of physician practices, starting from about $3,000 per procedure. Whether it is money well spent remains to be seen.

Body contouring and cellulite removal

Anther promising area for cosmetic use of ultrasound is body contouring and cellulite removal. Ultrasound can be calibrated to target subcutaneous fat tissue rather than the skin.

One approach is to use the settings that cause fat cells in the target area to burst. The fat is thus released and metabolized by the body. This supposedly leads to the removal of unwanted fat, i.e. something like a non-invasive liposuction. Another mode of treatment is used for cellulite, in which case the goal is not so much to eliminate the fat cells but to trigger the remodeling if the connective structures within the fatty tissue, restoring it to a healthier, more regular state.

Theoretically, the use of ultrasound for non-invasive fat removal and restructuring makes sense. Ultrasound can certainly burst open cellular membranes and hence destroy fat tissue cells. Scientists in cell biology labs routinely use ultrasound for precisely that purpose - to burst cells open in order to extract their content without using harsh solvents. However, laboratory experiment is one thing and clinical application in real people quite another. The few clinical studies conducted so far are interesting but not entirely conclusive and possibly contradictory.

A 2007 Spanish study looked into body contouring by non-invasive transdermal focused ultrasound. Thirty patients underwent three treatments each at 1-month intervals using UlrtaShape device. The treated areas were the abdomen, inner and outer thighs, flanks, inner knees, and breasts (males only). The researchers monitored change in fat thickness using ultrasound and circumference measurements. Safety was determined by clinical findings, serum triglycerides blood tests and liver ultrasound (to rule out fatty liver). While patients' overall weight was unchanged, all patients showed significant reduction in subcutaneous fat thickness within the treated area. Fat thickness in treated area was reduced my a mean of 2.28 cm (just under 1 inch) whereas circumference was reduced by a mean of 3.95 cm (over 1.5 inches).

A 2010 French study investigated body contouring using UltraShape Contour I System and a somewhat different protocol. Twenty-five healthy Caucasian women received three 30- to 90-minute Contour I treatments in the abdominal region at two-week intervals. Mean midline circumference (2 cm below midline) was reduced by 3.58 cm (just under 1.5 inches) on day 112 of the trial whereas thigh circumference (untreated area) was unchanged.

Both of the above studies appear to show dramatic and reliable body shape improvement following ultrasound treatment. However, a 2009 Hong Kong study conducted in fifty-three Southern Asian patients (51 females and 2 males) yielded very different results. The treatment of abdominal area by focused ultrasound produced no difference (as measured by ultrasound, abdominal circumference and calipers). The researchers hypothesized that Southern Asians responded differently than Caucasians due to smaller body figures and that design modifications could improve clinical outcome. However, it is also possible that the effectiveness of focused ultrasound for body contouring was overestimated by the European studies. Hopefully further studies will help to answer this question definitively.

Several commercial ultrasound devices for body contouring and cellulite removal are currently available (VelaShape, UltraShape, Liposonic) and more are likely to appear. The procedure typically costs about $500 - $2000 depending on the type/extent of the treatment and other variables. Whether it is worth the money is still somewhat unclear - more and better clinical studies are required.

Bottom line

Ultrasound appears to have considerable promise for skin tightening, body contouring and cellulite removal. It promises to be more than just another non-invasive directed energy treatment due to its capacity to be precisely calibrated and targeted to the desired structures without much collateral damage. The concomitant diagnostic utility of ultrasound may help to calibrate and target the treatment even further. That said, a lot more clinical research needs to be done before ultrasound rejuvenation is a definitely proven method rather than just an interesting new development.