Sept. 21, 2011 -- Wrinkle relief for those whose fear of needles outweighs their vanity may be on the horizon.
A topical gel containing botulinum toxin type A -- the same toxin as that used in injected Botox -- helped reduce moderate to severe crow's feet wrinkling around the eyes, according to two preliminary studies.
"The gel contains botulinum toxin type A and a peptide carrier, which is what helps the botulinum toxin gel penetrate the skin," says researcher Michael Kane, MD, a New York City plastic surgeon.
In two studies including 270 patients with mild to severe crow's feet, ''we found good effectiveness," he says. At the four-week mark, 89% of the patients in one study had some improvement in wrinkles around the eyes, he says.
He is due to present the results at Plastic Surgery 11, the annual meeting of the American Society of Plastic Surgeons, in Denver on Saturday.
The research was a phase II study. Phase III research is needed before seeking FDA approval. The research was funded by Revance Therapeutics, which makes the gel.
Wrinkle Relief Without Needles
Kane applied the topical gel around the eye area to reduce the crow's feet wrinkles. It is meant to reduce wrinkles by penetrating the skin and relaxing the underlying muscles.
"There is an applicator used to apply the gel to the area," Kane says. "The gel sits on the area for 30 minutes. Then it is wiped off and the patient walks out."
In one study, he assigned 90 patients to get either the new gel treatment or a placebo gel treatment.
After four weeks, both the patient and the doctor rated the results. They used a five-point scale.
Nearly 89% of the patients who got the active gel had at least a one-point or more improvement, compared to nearly 28% who got the inactive placebo. About 45% of those treated with the active gel had at least a two-point improvement or more on the five-point scale, Kane says. None in the comparison group had a two-point or more improvement.
In a second study, 180 patients were assigned to one of four groups:
- Treatment with the botulinum toxin gel in the carrier system that helps it penetrate
- The carrier alone
- The gel alone
- Placebo gel
After four weeks, the doctor and the patient rated the results. Nearly 41% of those treated with the gel and carrier showed a good response. In the comparison groups combined the good response rate was just over 1%.
No serious side effects were reported, Kane says. Side effects were typically mild, such as redness of the skin.
He calls the results ''a noticeable improvement.''
Kane is a consultant for Revance Therapeutics. He also reports consultant work for Allergan, Medicis Pharmaceutical Corp., and Merz, all of whom make wrinkle treatments.
On its company web site, Revance says it believes the new procedure could appeal to those ''who have considered treatment but are uncomfortable with the pain and bruising associated with injectables."
Besides Allergan's Botox, other cosmetic injectables include Dysport and Xeomin.
No head-to-head comparison has been made between the new Revance topical gel and injectables, according to Niquette Hunt, a Revance Therapeutics spokeswoman.
As it is not an approved drug, she says, "We have no comment on pricing."
How Does It Compare to Injected Botox?
The new option, if approved, is expected to appeal to patients wary of injections, says Marcel Daniels, MD, a plastic surgeon in Long Beach, Calif., who reviewed the study results for WebMD. He was not involved in the study.
"There is a fair amount of the American public who is needle-phobic," he tells WebMD.
However, he awaits a head-to-head comparison of the injected toxin products and the gel form, to see if the results are comparable.
That head-to-head comparison will be crucial, says Daniels. "I think what this very preliminary study shows is, there seems to be some benefit to it," he says of the new gel.
The studies reported by Kane only looked at crow's feet, Daniels says. Crow's feet skin is very thin, he says. So it is not clear whether the gel would work as well in other areas, such as on frown lines on the thicker skin between the brows. That is a popular site for injectables, Daniels says.
Prospective patients will also want to know if it costs about the same as the injectables, he says.
He cautions, too, that the product, if approved, should only be applied by health care professionals who have a working knowledge of anatomy, so they can apply it in precisely the right area.