In our constant search to bring our clients that latest advancements in Aesthetics and Anti-Aging treatments from around the world, I “stumbled across” research being conducted on “topical Botox”.
Industry-funded research has optimistically pinned the moderate success in the reduction of lines in the crows feet on the use of a topical gel that contains the active protein found in Botox. The excitement around this is based on the hope that we will no longer need to use needles to administer botox. How soon will the day arrive?
Very similar to injectected Botox, the effects of the gel, last for around three to four months, according to lead researcher Dr Michael Kane.
Dr Michael Kane, a plastic surgeon based in Manhattan, NY, is quoted saying that the gel “noticeably softened crow’s feet,” and was there for extremely encouraged by their initial research findings. 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 several years.
As the lead researcher however, he too is not quite certain what the actual implications of their discovery is. According to him there are several caveats. They are still unclear as to how much the treatment would cost, whether the gel would work better than injected Botox in all areas of the body and most importantly when it might be available.
The gel is “not commercialised, 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.”
The biggest advantage of the gel compared to injecting Botox, is that Botox injections can sometimes be uncomfortable or even be painful and may result in “the appearance of a ‘frozen,’ insincere smile,” according to the study abstract.
As part of the three phase study 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.
This is only the second of three phases of research required before a drug is approved by the U.S. Food and Drug Administration, so it will still be sometime before we see the drug come to our shores here in South Africa.
Although I am personally aware that Dr Desmond Fernandes, a Plastic Surgeon based here in Cape Town and founder of Environ is also conducting his own research on a similar gel.
Another advantage according to Dr. Seth Thaller, chief of the Division of Plastic, Aesthetic and Reconstructive Surgery at the University of Miami Miller School of Medicine, is that Botox injections can cause bruising, which a gel obviously would not. Therefore a pain-free, less expensive wrinkle treatment would likely boost the field of non-invasive cosmetic surgery.
Dr Thaller says “The gel is applied to the crow’s feet area, and it sits there for half an hour and is then wiped off,”
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.
Despite their drawbacks, Botox and Dysport (another muscle relaxant), are the most popular minimally invasive cosmetic surgery procedures performed in the United States, according to the American Society for Aesthetic Plastic Surgery.
In Dr Kane’s study some of the adverse effects included eye itching, flu-like illness and urinary tract infection. Whether these were directly related to the gel or not is not conclusive, but is unlikely.
For those Physicians worried that they would lose their regular Botox clients, the gel would be regarded as a drug rather than a skin cream, according to the study authors, so patients could only undergo in the procedure at a physician’s office.
Another draw back of the gel according to Dr Thaller is that 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 said.
However, he still believes, there’s a big advantage to a gel as compared to an injection: “No needle.”
The findings of these studies were to be released at the American Society of Plastic Surgeons annual conference in Denver last month. In my view this type of research presented at meetings should always be considered preliminary until published in a peer-reviewed medical journal.
Although it might be a year or two before these innovations reach us here in South Africa, it is exciting to know that more and more our treatments are becoming minimally invasive.
Till next month