Botox Cosmetic was approved by the FDA for the cosmetic treatment of frown lines back in 2002. Since that time, millions of Americans have been successfully treated with Botox, making it the most popular non-surgical aesthetic treatment in the United States. It is now also widely used for wrinkles in other areas of the face, including the forehead, crow’s feet and even in areas of the lower face such as lip lines and chin dimpling. Despite the fact that the market for injectable Botox continues to grow, many people are still too afraid of injections in their face to pursue the aesthetic benefits of Botox.

Fast forward to about 2010, when a small, privately held biotechnology company named Revance announced the results of a Phase II clinical trial of an investigational drug it calls RT001. This drug is actually a topical gel formulation of the botulinum toxin present in injectable Botox. In this study, Revance showed that its topical botulinum toxin gel was superior to placebo gel in reducing the crow’s feet wrinkles in study participants. Imagine, a gel you can apply to the skin around your eyes that will significantly improve your crow’s feet!

RT001 is a gel formulation that contains botulinum type A toxin and a novel peptide developed by Revance. This proprietary peptide enables the “transcutaneous” delivery of the botulinum toxin, meaning it can help the toxin penetrate the skin to get to the muscle, which is where the toxin works to produce the desired cosmetic effect.  In the study, the gel was applied to the skin of the crow’s feet area, covered with a dressing and left on for 30 minutes. Then, the gel was removed, and the study participants repeated this procedure at 4 weeks after the initial application. Four weeks after the second application, the study authors reported that over 94% of the study investigators rated the improvement in crow’s feet lines as greater than a 1-point improvement over baseline, based on a 5 point crow’s feet severity scale. Also of note is that no serious side effects were seen in the trial.

The obvious next question is how does this compare to injectable Botox. Those studies have yet to be done, and even Phase III trials will still need to be done on RT001 before it can be approved by the FDA.  Also, the muscle around the eye that gives rise to crow’s feet is just under the skin in that area, making a topical formulation easier to use.  RT001 may have limited effect when applied to other wrinkle areas like the frown because of the limitation of penetrating deeply enough into these muscles. However, the appeal of a topical botox gel is obvious for those people who are afraid of needles and those who cannot or won’t risk the bleeding and bruising that may occur in such a sensitive area as the crow’s feet.

Another potential area of application for a topical botulinum toxin would be for excessive under-arm sweating. Botox works very well in this area, but many patients are afraid of the multiple injections under the arm that are required. If a topical botulinum toxin gel could be shown to significantly reduce axillary sweating like injectable Botox does, the ease of use and the increased comfort for the patient would be a major selling point.

Stay tuned for further developments in this exciting area of aesthetic medicine.