GRAPEVINE, TEX. – An investigational cryoprobe device reduced dynamic forehead wrinkles immediately after application in a pilot study of 36 patients that was presented at the annual meeting of the American Society for Laser Medicine and Surgery.
The self-contained, hand-held device, made by MyoScience Inc., uses a 27-gauge needle to deliver cooling to the temporal branch of the facial nerve that controls the frontalis muscle, rather than directly into the muscle as is done with botulinum toxins. The duration of effect is similar to that of botulinum toxins, about 3-4 months.
"Basically, it's a green alternative. There's no chemical, no toxin, it's only cold therapy," principal investigator Dr. Francis Palmer said in an interview.
Dr. Vic Narurkar
Results from the use of a first-generation version of the device were reported by Dr. Vic Narurkar, who directs the Bay Area Laser Institute in San Francisco. The 36 patients were aged 35-70 years, all with forehead lines during animation. Some were at risk for brow ptosis.
After lidocaine administration, the probe was inserted for 30-45 seconds, and the subsequent reduction in muscle contractility was monitored to see if additional cryoprobe insertions were needed. All patients had immediate dynamic line reduction after two to four cryoprobe insertions, Dr. Narurkar reported.
The most common adverse events were headaches and small focal areas of minor epidermal cold injury, attributed to limitations in the prototype design. No patient experienced ptosis. "Cold has the unique natural property of selectively affecting the axon, yet preserves the endoneurial sheath. ... [It] has no impact on collagen-based structures," Dr. Narurkar explained.
According to Dr. Palmer, both the absence of ptosis risk and the immediacy of the response represent significant advantages over botulinum toxins, for which peak of action is typically 4-7 days following injection.
However, "I don't see this as a replacement for toxin, but as a complement. Physicians now have something to give patients who don't want a toxin, or for use in combination in areas where you can’t use a toxin. Botox is fabulous. It doesn't need to be replaced," said Dr. Palmer, director of the Beverly Hills (Calif.) International Center for Aesthetic Surgery.
Moreover, he noted, at this point, the injection of neurotoxin is easier and somewhat less invasive, although that could change with further revision of the cryoprobe's design. "We think it offers additional things toxin therapy doesn't offer, but it’s in a very early stage. It will be refined further before it hits the market."
MyoScience plans to seek a CE marking for the cryoprobe later this year before approaching the U.S. Food and Drug Administration, he said.
Both Dr. Palmer and Dr. Narurkar are paid consultants for MyoScience, which funded the study.