- The topical reportedly allows large macromolecules to cross the skin and other barrier membranes enabling local, targeted delivery.
- Delivered through TransMTS (Macromolecule Transport Technology), the neurotoxin is based on a single, straight-chain, peptide that allows skin to be a gateway for drug delivery, rather than a barrier.
NEW YORK – A topical, noninjectable form of botulinum toxin asserted its ability to effectively treat crow's feet through impressive data from a recently completed phase II clinical trial released here.
Seventy-five patients at four study sites were treated with the novel topical toxin or placebo to the crow's feet area. On a four-point static scale, a significant number of participants showed two point moves, according to Michael Kane, M.D., a principal investigator in the trial who released aggregate data from the study at the American Society for Aesthetic Plastic Surgery annual meeting.
"As one of the study centers, I was not unblinded as to which of my patients had toxin and which were [treated with] placebo. But, clearly, by looking at the patients, there were those whose crow's feet got a lot better and some whose didn't," Dr. Kane, a plastic surgeon in private practice in New York City, tells
Cosmetic Surgery Times
. "The difference was night and day, both at rest and smiling. The people who showed significant difference, unsurprisingly, had lateral brow elevation, as well. Obviously, the toxin was working on the muscle."
TRANSDUCTION TRANSFORMATION The concept of simply applying a topical to eliminate wrinkles is not new, but proving the theory has yet to be conclusively accomplished. Yet, researchers involved with the development of the topical form of botulinum toxin think they are close. Its developers at Revance Therapeutics, Inc., a privately held company based in Mountain View, Calif., claim that the topical allows large macromolecules to cross the skin and other barrier membranes enabling local, targeted delivery. Delivered through the firm's proprietary TransMTS™ (Macromolecule Transport Technology), the neurotoxin is based on a single, straight-chain, peptide that allows skin to be a gateway for drug delivery, rather than a barrier.
"Adding a peptide as a separate component within the [toxin] formulation allows the toxin to cross the skin," explains Jacob Waugh, M.D., co-founder & chief scientific officer, Revance. "The peptide forms an ionic bond with the toxin and the peptide also has a Protein Transduction Domain (PTD), which is responsible for transcutaneous flux. It is essentially a quite broad and powerful transduction." Although the topical toxin's technology is fairly obscure and complex, the use of two pathways on both the dead and living layers of the skin allows for a significant result, according to Dr. Waugh. Currently, there have been 600 crow's feet areas treated via the TransMTS™ technology, with a fairly low local irritation rate and no evidence of adjacent paralysis above placebo grade, say the developers.
"TransMTS technology relies on the fluidity of the dead skin, that essentially is the equivalency of the typical topical that loads the stratum corneum, but more interesting is the second pathway that [also] happens on the living cells," Dr. Waugh details.
"Basically, it's a variation the cell uses to take a drink, then it dumps the drink back out on the other side of the cell."
The key to TransMTS technology, say its developers, is a protein carrier featuring protein transduction domains that hold on to the cell membrane and allow larger molecules to pass through it undisturbed. The transport technology is also currently being studied for early applications of new cardiovascular disease drugs. Additionally, three different cancer drug trials are being investigated based on the system's ability to transport molecules, according to the firm.