Electric pulses used to remove wrinkles
When a Stanford facial plastic surgeon needed volunteers for his latest clinical trial, he didn't have to advertise. Patients flocked to him, he said, eager to help test the latest scalpel-free, toxin-free, laser-free approach to easing facial wrinkles and sags. The electrical treatment takes just minutes, and results often improve for months to come, as facial tissues gradually re-mold and wrinkles fade.
R. James Koch, MD, assistant professor of otolaryngology/facial plastic and reconstructive surgery, said he usually has all the study subjects he needs within hours of when the word hits the grapevine. He recently completed his second study of skin and soft-tissue tightening using the ThermaCool system, which works by radiofrequency heating of skin and under-skin tissue.
The take-home message from the latest trial, Koch said, is that the electrical device does tighten and lift facial tissue, especially along the jaw line. And outcomes are best, he said, when treatments are tailored to each individual's one-of-a-kind face.
Koch, whose earlier study explored ThermaCool's eyebrow-lifting potential, said the more recent trial was designed to test the notion of using low-energy electrical pulses. In the past, physicians delivered a single high-energy zap to each little patch of skin. "That was the 'no-pain, no-gain' type of approach," said Koch. The latest method uses lower energy and re-visits problem areas three or more times. The new results are "as good or better," Koch said, "and less painful and probably safer."
So how does it work? Nurses first apply and remove numbing cream, then temporarily tattoo little squares on the patient's face. A typical forehead gets about 80 squares, Koch said; a lower face, about 120, and an average neck, about 70. Next comes a layer of clear gel on the patient's face and a blue plastic pad on the patient's back, to help route the electricity.
Koch places the flat tip of a hand piece, reminiscent of a videogame controller, on the patient's skin. At each little inked-on square, he pulls a blue trigger, signaling the system to pre-cool the skin, emit an electrical pulse to heat under-skin tissue, then deliver a final cooling. The whole cycle takes about two seconds, he said. Each area--forehead, lower face and neck--takes about 20 to 30 minutes to cover.
The radiofrequency energy selectively heats fibrous connectors that attach muscle to the skin's underside, Koch said. In response, those connectors contract, and some patients see results immediately. Most patients, he said, see positive changes over the next several months as collagen heals and re-forms.
All of the 25 Stanford trial subjects showed "at least good improvement" four months after treatment, as measured by physician assessment, and about 90 percent maintained that level of improvement at the six-month mark, Koch said. Almost 70 percent of the patients were satisfied with the six-month outcome.
Investigators also monitored treatment effectiveness with a high-tech device that measured skin properties. "All the Stanford patients had an improvement in skin stiffness, energy absorption and laxity," said Koch of the measurements four months after treatment. "And 83 percent improved in elasticity." At the six-month mark, the numbers were 68 percent for improved skin stiffness, 84 percent for laxity and 76 percent for elasticity.
The most common side effects observed by the research team, which included Karen Kim, MD, and Roy Geronemus, MD, of the Laser and Skin Surgery Center of New York, were temporary redness and swelling. About 40 percent of the multicenter trial's 50 patients, who ranged in age from 38 to 62, showed mild redness after treatment. About 20 percent experienced mild swelling.
Researchers found that individualizing each patient's treatment?by adjusting the energy level and number of pulses for each new face?contributed to better outcomes, Koch said, in terms of fewer complications, improved tissue properties and higher patient satisfaction. "This was the first study to really point that out," he noted.
Koch said many patients now come for yearly radiofrequency tune-ups. At this time, he said, each of the three facial areas costs about $1,500 to treat.
It's not clear yet who is the ideal patient. One would think, Koch said, it would be someone with not-too-severe wrinkles, a good amount of collagen, and the ability to mount a wound-healing response. "But," he added, "you get these surprises." About four-fifths of the time, he said, the outcome is predictable. But about 10 percent of his patients do worse than he would expect, and about 10 percent do better.
For dramatic results and predictability, "surgery is still the gold standard," said Koch, who also has expertise in wound healing and laser surgery. "If people expect a surgical result" from noninvasive methods, "they're not going to get it at this time."
Still, he said, the ThermaCool system offers a popular complement to surgery and other methods. Unlike botox injections, it does not paralyze muscles. And, unlike surgery, the half-hour radiofrequency technique requires no antibiotics and no two-week healing period. "It's nice to have," Koch said, "for people who want kind of a lunchtime procedure."
The trial was funded by Thermage Inc., the Hayward, Calif., company that developed the ThermaCool system. Koch is a member of Thermage's scientific advisory board. Co-author Kim presented the multicenter trial results at the March 2005 annual meeting of the American Society for Laser Medicine and Surgery in Lake Buena Vista, Fla.