PARIS A new device that uses vacuum suction in combination with radio frequency painlessly treats facial lines and wrinkles, Michael H. Gold, M.D., reported at the Fourth International Academy of Cosmetic Dermatology World Congress.
Radio frequency (RF) devices have been used successfully over the last 5 years to improve skin texture and laxity, but their use has been limited because patients complain the treatments are too painful, said Dr. Gold of Nashville, Tenn.
Efforts have been made with varying degrees of success to reduce the pain by changing machine parameters, using multiple passes at lower power, or by incorporating RF with intense pulsed light devices. General anesthesia or intravenous medications have been used, but few patients have been willing to incur the associated risks.
The new bipolar RF device, Aluma Skin Renewal System (Lumenis Inc.), uses vacuum suction to pull the skin about one-quarter inch into the vacuum, where there are RF electrodes on either side.
The device holds the skin for 1 second of vacuum at 20-mm Hg suction and delivers about 10 W of RF energy, he said. The overall treatment takes 1530 minutes and treatments occur once weekly for 58 weeks. How the device reduces pain is unclear.
"I think because we're taking up the skin and compressing the nerves or the circulation affecting those nerves, we're doing something. We're just not sure what, but it is effective and doesn't hurt," Dr. Gold said in an interview.
In a study of 46 patients aged 3065 years with periorbital and nasal labial wrinkles, 1%2% of patients reported pain with the first two treatments. Patients reported pain of 0 or 1 on a 4-point scale, with 0 being no pain and 4 being intractable pain, he said. Seven patients were lost to follow-up. No one dropped out of the study because of pain or an adverse event, said Dr. Gold. All of the 39 patients who completed the study had at least a 50% improvement in wrinkling based on evaluation by blinded clinicians. Patients were able to maintain the improvements 6 months posttreatment.
The maximum benefit is seen after the fifth or sixth treatment. The optimal number and best interval between treatments have yet to be determined. Studies are planned to evaluate the device to reduce tissue laxity on the jowls, upper arms, stomach, and thighs. The device will be launched in the United States and Europe this month.
Dr. Gold is an investigator, advisory board member, consultant, and stockholder with Lumenis Inc., and has received honoraria to speak on behalf of the company.