FRIDAY, April 1 (HealthDay News) -- A new technology that
temporarily zaps away forehead wrinkles by freezing the nerves
shows promise in early clinical trials, researchers say.
The technique, if eventually approved by the U.S. Food and Drug
Administration, could provide an alternative to Botox and Dysport.
Both are injectable forms of Botulinum toxin type A, a neurotoxin
that, when injected in small quantities, temporarily paralyzes
facial muscles, thereby reducing wrinkles.
"It's a toxin-free alternative to treating unwanted lines and wrinkles, similar to what is being done with Botox and Dysport," said study co-author Francis Palmer, director of facial plastic surgery at the University of Southern California School of Medicine in Los Angeles. "From the early clinical trials, this procedure -- which its maker calls cryoneuromodulation -- appears to have the same clinical efficacy and safety comparable to the existing techniques."
Palmer is also consulting medical director of MyoScience, Inc.,
the Redwood City, Calif.-based company developing the
"cryotechnology."
The results of the clinical trials were to be presented Friday
at an American Society for Laser Medicine and Surgery (ASLMS)
conference in Grapevine, Texas.
To do the procedure, physicians use small needles --
"cryoprobes" -- to deliver cold to nerves running through the
forehead, specifically the temporal branch of the frontal nerve,
Palmer said. The cold freezes the nerve, which interrupts the nerve
signal and relaxes the muscle that causes vertical and horizontal
forehead lines.
Although the nerve quickly returns to normal body temperature,
the cold temporarily "injures" the nerve, allowing the signal to
remain interrupted for some period of time after the patient leaves
the office.
The technique does not permanently damage the nerve, Palmer
said.
Researchers said they are still refining the technique and could
not say how long the effect lasts, but it seems to be comparable to
Botox, which works for about three to four months, Palmer said.
Physicians would need training to identify the nerve that should
be targeted, he added.
The 15-minute treatment is done using local anesthesia,
according to the researchers. The current study only looks at
forehead wrinkles; future research will study the procedure
elsewhere on the face, Palmer said.
For the study, researchers tried the technique on 31 people, all
of whom had fewer wrinkles after two to eight injections. The most
common side effects were headaches and skin redness. The level of
discomfort was comparable to that from Botox or fillers, Palmer
said.
But unlike Botox, which takes a few days to kick in, the effects
of the cryotechnology are seen immediately, the researchers
say.
Because this study was presented at a medical meeting, the data
and conclusions should be viewed as preliminary until published in
a peer-reviewed journal.
Palmer said he didn't see the new technology as a replacement
for Botox, but instead as an alternative for people who don't want
an injection of a neurotoxin.
The company will eventually seek FDA approval as a medical
device. Palmer said the company might first seek approval in
Europe.
Dr. Brian Zelickson, an associate professor of dermatology at
the University of Minnesota in Minneapolis, said the technique
sounds promising, but needs more research to determine how long
results last and to make sure no lasting nerve or muscle injury
occurs that could cause permanent changes in sensation.
He agreed that the toxin-free cosmetic procedure might win some
followers.
"Botox and Dysport are very easy, very quick, the patient satisfaction profile is great and there are very few side effects," said Zelickson, incoming president of ASLMS. "It's a high bar to leap over, but there are some people that don't like the concept of injecting Botulinum toxin into their bodies. If there were a procedure that could be done, that doesn't inject any chemical into the system and could yield the same results for the same duration, there is a market for that."
According to the American Society for Aesthetic Plastic Surgery,
Botox and Dysport injections top their list of nonsurgical
procedures.
More information
The
U.S. National Library of Medicine has more on
Botox.