Ultimately it will stimulate the market and sustain patient care.
There are already three FDA-approved toxins on the market, yet there is still a substantial amount of hesitation on the part of some consumers to be treated with toxins as a category. The fact that the FDA has approved a fourth one can only help. Hopefully other areas where we already use toxins off label will see new trials starting for FDA approval.
Jeffrey Dover, MD: RT performed remarkably well and consistently in the three Sakura trials performed in almost 2, individuals. The first two were control blinded trials of single treatments of glabellar lines, and the third was a long-term open label trial where subjects received as many as three sequential treatments for glabellar creases. Each of the studies showed not only that the effect of RT on glabellar lines was impressive but also of long duration. A positive result was considered a two-grade improvement from severe to mild glabellar lines or from moderate to no glabellar lines.
The percentage of individuals who showed a two-grade improvement was greater than we have seen with any of the other neuromodulators studied in this manner. Moreover, the median duration of effect was over six months, compared to the conventional neuromodulator effect, which is about four months.
The fact that the effect of RT lasted an average of six months—a full 50 percent longer than what we see with all other neuromodulators—will have a significant impact on aesthetic medicine. The neuromodulators presently approved for use in the US last on average four months. Patients will now have a choice to make. They can opt to sticking with the gold standard toxins we have used for years, which give very nice results that last about four months, or the choice of an innovative treatment that is very safe, highly effective, and lasts 50 percent longer, or about six months.
The ability to have a treatment twice a year instead of three times a year will be highly desirable for many of our patients.
Dover: Three things stood out from the Sakura 3 trial: safety, efficacy, and long duration. Side effects were mild and insignificant; exactly as we would expect with any type A botulinum toxin.
RT is highly effective. The peak effects started about 10 days after injection. The percentage of subjects with a two-grade difference was greater over four months than we have seen with any other neuromodulators tested in this manner. Perhaps most striking was the duration of effect that approached six to seven months, compared with the typical effect of neuromodulators, which is around four months.
Dover: RT is a type A neuromodulator with unique characteristics that appear to account for the significant aesthetic effect and long duration. RT is the only neuromodulator using a proprietary stabilizing excipient peptide technology in its formulation, which may explain the high efficacy, long duration and a two-year product stability requiring no refrigeration. Dover: The holy grail for neuromodulators is longer duration without sacrificing safety.
Reader Comments. Mechanism of Action.
Botulinum Toxin in Clinical Dermatology: Medicine & Health Science Books @ ykoketomel.ml Buy Botulinum Toxin in Clinical Dermatology: Read Kindle Store Reviews - ykoketomel.ml
Indications and Uses. Dosages and Admi Adverse Effects.
How to cite this article: Savardekar P. Botulinum toxin. Indian J Dermatol Venereol Leprol ; Dosages and Administration. Erbguth FJ, Naumann M.
Historical aspects of botulinum toxin: Justinus Kerner and the "sausage poison". Neurology ; Preparation and characterization of botulinum toxin type A for human treatment.
In: Jankovik J, Hallet M, editors. Therapy with Botulinum Toxin. Vol New York: Marcel Dekker; Benedetto AV. The cosmetic uses of Botulinum toxin type A. Int J Dermatol ; Cosmetic denervation of the muscles of facial expression with botulinum toxin: A dose-response study.