By Brian Kobienia, MD, FACS on December 15, 2011
If all you want for Christmas is a wrinkle treatment that does not involve needles your wishes may be coming true. At the recent American Society of Plastic Surgery meeting several studies on the topical version of botulin neurotoxin A (botox) were reported. The topical (RT001) botox is an investigational application with a novel protein delivery system that enables transcutaneous transfer of the Botox protein to the desired muscle of choice. Phase 2 randomized double blind trials report effectiveness in reducing latheral canthus lines (crow’s feet). There were no treatment related adverse effects. The results closely mimic the clinical effectiveness of the injectable form of Botox.
Another phase 2 trials on RT001 involving over 500 patients reveal the topical wrinkle treatment has a duration of effect of 115 days. Again no adverse effects were noted and the agent did not appear to diffuse or spread beyond the treatment area.
So when can we expect this new form of botulin neurotoxin to be clinically available? Much more detailed and lengthy phase 3 and 4 trials still need to be initiated and completed. These trials will look further into details on areas of application and potential side effects. After these trials, the Federal Drug Administration (FDA) needs to approve the use of this aesthetic medicine. Unfortunately, the FDA is notoriously unpredictable. The medical-industrial complex that tends to behave conservatively on the shores of the USA will take advantage of European and Third World markets to gather and implement the data so look to see topical Botox available much earlier outside the USA.
So will this revolutionize aesthetic medicine?
Not really. Topical Botox will certainly make it less painful and likely less likely to cause bruising when getting treated, but the effects and potential side effects will likely be the same. The use of the topical Botox may never make it to be an over the counter medicine due to misuse leading to significant morbidity (think rubbing it into the eye leading to eye muscle disfunction). Other uses of this medication that may benefit from the topical application is in the realm of rehabilitation medicine where children with spastic arms and legs may expect easier, less painful administration of this life changing medication.
So keep holding on to your Holiday Wishes. They will soon come true.
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