The macromolecule transport system technology is based on transactivator of transcription (TAT) proteins, which carry the drug to a specific depth. A negatively charged core with a sequence of positively charged consecutive lysines bonds to a negatively charged macromolecule. RT001 pairs this peptide with a purified 150 kDa BoNT-A molecule.
I work as a clinical investigator for Revance, and, in the studies I participated in, RT001 appeared to show safety and efficacy. The final decision regarding safety and efficacy, of course, resides with the FDA. Revance RT001 is currently in phase 2 clinical trials, so this article contains forward-looking statements. The two-point change (on a four-point scale) seen with RT001 compares with published studies of injectable botulinum toxin in the crow’s feet area, and I was additionally intrigued by the apparent fundamental change in the skin at rest. Spread of injectable toxin outside of the crow’s feet treatment area has been reported, which can affect the zygomaticus and other surrounding muscles and result in significant change during maximum expression (smiling). RT001 appears to be able to remodel the skin structure at the target site for significant improvement of wrinkles at rest, and investigators did not see any effect of the drug outside of this area.
I found the topical gel to be easy to work with. Just like other BoNT-A formulations, RT001 should be stored in the refrigerator, and it is packaged in a proprietary device that enables both simple reconstitution and application to the skin. It is designed to be an in--office medical procedure. When it is applied to the skin, the gel is the consistency of a thick lotion and it is placed where the drug effect is desired.
In my opinion, RT001 has the potential to improve the safety and tolerability of BoNT-A over current injection therapies, expand the treatment options for current patients, and also encourage new patients to enter the botulinum toxin treatment market.
This 59-year-old woman is shown before treatment and 4 weeks after treatment with Revance topical toxin RT001 (Fig. 1).
See Editorial Commentaries by Dr. Jason N. Pozner and Dr. Gary D. Monheit on page 3