Wave of the future

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Initial testing suggests that a newly developed high-frequency ultrasound device could become a viable option for cosmetic surgeons in facial skin-tightening procedures

GRAPEVINE, TEXAS — The first phase of clinical testing is complete on a new device that, if approved by the FDA, will provide cosmetic surgeons with another alternative for treating sagging facial skin. That approval, says Murad Alam, M.D., could come within a year. Dr. Alam, assistant professor of dermatology, otolaryngology and surgery, and chief of cutaneous and aesthetic surgery at Northwestern University's Feinberg School of Medicine, heads the research team that recently completed the initial safety phase of testing on the new device. Dr. Alam presented results of this testing phase at the American Society for Laser Medicine and Surgery (ASLMS) meeting recently held in Grapevine, Texas. Developed by Ulthera (Mesa, Ariz.), the device moves away from light, laser, radio-frequency (RF) and vacuum devices used for skin-tightening procedures, instead using high-frequency ultrasound technology, which hasn't previously been used in such procedures:

Dr. Alam

TARGET TREATMENT "The theory behind the Ulthera device is that in the last 10 to 15 years, there's been a trend from more invasive to less invasive skin-tightening therapy," Dr. Alam tells Cosmetic Surgery Times . "Increasingly, patients want treatments that are minimally painful, require little downtime and, of course, are effective. Also, in recent years, people are undergoing these procedures at a younger age and don't need complete facelifts." The challenge, explains Dr. Alam, is to maximize tightening, minimize pain and downtime, and still achieve quality results that last for a reasonable amount of time. While in his opinion light, laser, RF and vacuum devices are a step above invasive surgical techniques in meeting this challenge, they can fall short in precisely and efficiently focusing energy deep into the superficial muscular aponeurotic system (SMAS) directly above the facial musculature without damaging the shallower layers through which the energy must pass.

"This device uses ultrasound waves that can be exactly targeted to the deepest layers of skin without dissipating into the more surface layers," says Dr. Alam. "Light, laser and RF energies dissipate as they pass through shallow skin layers to the SMAS, which is the layer that needs to be tightened for the most effective results."

In his ASLMS presentation, Dr. Alam explained that current light, laser, RF, vacuum or combination technology delivers energy into the dermis or subcutis with minimal to moderate discomfort and "modest results, uncertain persistence [and] variable patient satisfaction." Areas of desired improvement in skin-tightening technology, he noted, would be more tissue shrinkage — and, thus, tightening — with continued safety and tolerability and higher levels of patient acceptance.

PROMISING OUTCOMES So far in clinical testing, says Dr. Alam, the device has exhibited potential to make those desired improvements. His team's research involved 35 adult subjects, most between the ages of 40 and 65, with mild to moderate facial laxity. About half had received previous cosmetic procedures, though none had undergone tightening procedures within the prior year. Patients were given full face and neck treatments with a single pass of one of two Ulthera transducers: a 7.5-MHz transducer with 4.5-mm focal depth for temple, preauricular, submental and neck areas, or a 4.4-MHz probe with 4.5-mm focal depth for the cheeks. A handpiece was used first to image the treatment area, then energy (0.4 J to 1.2 J) was placed in linear arrays up to 25 mm long and spaced about 5 mm apart.

Outcomes were measured as follows: double-blinded rating of pre- and post-treatment photographs taken before and after treatment, and at two, seven, 28, 60 and 90 days after treatment; quantitative assessment of brow-line elevation; physician grading of physical features (e.g., hypo- and hyper-pigmentation, vascularity, texture, pliability, laxity); and patient self-assessment of efficacy as well as subjective pain scores.

The trial showed the device to be an effective modality that resulted in a favorable, quantitatively verifiable brow lift; reduction of forehead and crow's feet lines, and improved neck definition, both verified by blinded raters.

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Wave of the future

Article-Wave of the future

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