TUESDAY, Sept. 20 (HealthDay News) -- Preliminary
industry-funded research suggests that a gel based on the active
ingredient of the injectable Botox wrinkle treatment could help
reduce the lines around the eyes known as crow's feet -- without
the pain of needles.
The effects of the gel, which uses botulinum toxin, last for
about four months, comparable to that produced by Botox injections,
the researchers said.
The new study is encouraging since it showed that the gel
"noticeably softened crow's feet," said study author Dr. Michael
Kane, a plastic surgeon at the Manhattan Eye, Ear and Throat
Hospital in New York City. He has served as an investigator and
consultant to Revance Therapeutics of Mountain View, Calif., the
gel maker that has been trying to develop a Botox alternative for
There are several caveats, he pointed out. It's not clear how
much the treatment would cost, whether it would work better than
injected Botox or when it might be available.
The gel is "not commercialized, it's not approved," Kane said,
noting the research is part of a phase II clinical trial. "No one
is going to be running to the doctor and getting this until phase
III studies are done and the FDA rules."
Botox -- produced, like the gel, from the botulinum toxin --
weakens or paralyzes muscles or nerves. In targeted injections,
cosmetic plastic surgeons use small doses of it to smoothe facial
Botox treatment can be painful and cost hundreds of dollars,
however, and may result in "the appearance of a 'frozen,' insincere
smile," according to the study abstract. And Botox injections can
cause bruising, said Dr. Seth Thaller, chief of the Division of
Plastic, Aesthetic and Reconstructive Surgery at the University of
Miami Miller School of Medicine.
A pain-free, less expensive wrinkle treatment would likely boost
the field of non-invasive cosmetic surgery. Despite their
drawbacks, injections of Botox and another wrinkle relaxer,
Dysport, are the most popular minimally invasive cosmetic surgery
procedures performed in the United States, according to the
American Society for Aesthetic Plastic Surgery.
In part of the new study -- the second of three phases of
research required before a drug is approved by the U.S. Food and
Drug Administration -- 90 patients with moderate to severe wrinkles
around the eye were randomly assigned to receive an application of
a placebo gel or the botulinum toxin gel.
"The gel is applied to the crow's feet area, and it sits there for half an hour and is then wiped off," Thaller said.
Almost 90 percent of those who got the gel showed what
researchers called a "clinically meaningful" reduction in wrinkles,
compared to 28 percent of those who got the placebo.
In a second study involving 180 adults with crow's feet, about
40 percent of those treated with the gel responded favorably, the
Kane said adverse effects were not related to the study
treatment, and included eye itching, flu-like illness and urinary
The gel is a drug rather than a skin cream, the authors noted,
so patients could only undergo in the procedure at a physician's
Thaller said it may be difficult for a gel to reach the level of
wrinkle-softening precision that injections provide. "With the
needle, you can really pinpoint the muscles you're injecting," he
Still, he said, there's a big advantage to a gel as compared to
an injection: "No needle."
The findings are scheduled to be released Saturday at the
American Society of Plastic Surgeons annual conference in Denver.
Research presented at meetings should be considered preliminary
until published in a peer-reviewed medical journal.
For more on
Botox, visit the U.S. National Library of Medicine.
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