The world of aesthetics is expanding every day. Every few months a new product or device is released and from time to time products and devices are cleared or approved for different treatments. For example, in the past couple of years multiple devices have been released which stimulate muscle growth. And Botox cosmetic, which was originally only approved to treat frown lines between the eyebrows, is now approved to treat crow’s feet around the eyes and horizontal forehead wrinkles.
What is a clinical trial?
A clinical trial is a study set up to test whether a product or drug works and if it is safe. These trials are very expensive and usually take several years. This is the main reason why new drugs are so expensive. Once the clinical trial is complete, the results are submitted to the FDA for approval. The FDA reviews the results to make sure the drug works and that it is safe. Often times, the FDA requests changes that require more testing, which can further prolong the process. One way that doctors are able to get around this is by using products in an off-label manner. This is what was done when Botox was used to treat crow’s feet and horizontal forehead wrinkles before it was approved. Off-label means that the product is approved for a different treatment, in this case frown lines, but not the specific treatment it is being used for. Medications are routinely used off-label throughout medicine. Once a drug is approved for a new indication, the company can then market it and generate more revenue. There are many ongoing clinical trials for Botox and a variety of fillers.
Botox Clinical Trials
Botox is a purified protein used to treat wrinkles associated with facial expression such as the vertical lines you see between your eyebrows when you frown, the horizontal lines you see on your forehead when you raise your eyebrows, and the crow’s feet you see around your eyes when you smile or squint. Botox works by relaxing muscles and smoothening our wrinkles. There are currently three alternatives to Botox in the United States: Dysport, Xeomin, and Jeuveau. However, these three are only approved to treat frown lines in the United States. Overseas, on the other hand, some are approved for treatment of other areas. This gives Allergan, the manufacturer of Botox (as well as Juvederm, Voluma, Vollure, Volbella, and Kybella) a big advantage in the United States.
To sustain this advantage, Allergan is currently conducting clinical trials for the use of Botox to treat other areas. One area is treatment of the masseter muscle. This is the main muscle you use to bite. Some people have very strong and large masseter muscles, usually from grinding or clenching their teeth. This can cause pain near the ear called TMJ pain. It can also lead to a bulky appearance in the lower face, which often makes a female face look more masculine. Dr. Alex routinely treats the masseter muscle with Botox to shape the lower face and decrease pain. Upon completion of this current clinical trial for Botox, Allergan will be able to do more marketing on this indication, which will educate the public and provide more opportunities for people who desire such treatments.
Another ongoing clinical trial is for the use of Botox in the platysma muscle. The platysma muscle is a thin muscle just beneath the skin in the neck that goes from the jawline to the collar bone. Some people contract this muscle very often and have vertical neck bands. Dr. Alex uses Botox to relax this muscle to decreases the appearance of these unwanted neck bands. The platysma muscle also pulls down on the skin in the lower face. After it is relaxed with Botox, you can see a lift in the lower face. This is called the Nefertiti neck lift and is a very popular treatment, especially when combined with treatments such as Voluma in the mid-face, laser skin tightening of the face and neck, and Kybella in the neck.
Fillers: Voluma, Vollure, Volbella, Volux
Unlike Botox, fillers such as Voluma, Vollure, and Volbella restore lost volume in the skin. The active ingredient in these products is a sugar called hyaluronic acid which draws water into the skin to fill in wrinkles, folds, and hollow areas. In the United States Voluma is only indicated for treatment of the cheeks, Vollure for the laugh lines (also called nasolabial folds), and Volbella for the lips and the area around the lips. However, Dr. Alex routinely uses these products off label to treat hollow temples, bumps on the nose, tear troughs under the eyes, the chin, the jawline, and backs of the hands. Allergan is conducting a number of clinical trials to get Voluma, Vollure, Volbella, and another product called Volux currently only available overseas approved for many of these indications.
Approval of Botox, Voluma, Vollure, Volbella, and Volux for new indications will allow aesthetic providers to offer a more comprehensive portfolio of treatments for our patients. Fortunately, Dr. Alex is ahead of the game and is already using many of these products off-label for his patients.