The FDA and BOTOX®: South Carolina’s Dr. Marguerite Germain Discusses Their Relationship

In early October, cosmetic treatment manufacturer Allergan announced that the FDA had given approval to a new cosmetic use for BOTOX®. South Carolina’s Dr. Marguerite Germain—a board-certified dermatologist and founder of Germain Dermatology—particularly noted this news, since she trains medical professionals nationally and internationally in BOTOX^® injections, allowing her unique insight into the muscle-relaxer’s many uses.

Given that BOTOX^® is used as a treatment for so many conditions, seeing a new FDA approval bringing the official total up to three may cause confusion for some patients who wonder whether the injections they’ve been considering—or already received—were safe.

For these women and men, comfort lies in a greater understanding of what an FDA approval means and how BOTOX^® is used.

First, it is important to know that BOTOX^® has two uses: medical and cosmetic. Long before it was making headlines for smoothing out lines on the head, the injectable was being used to calm otherwise uncontrollable muscle activity. The FDA has overseen numerous trials, resulting in more than half a dozen approvals for medical uses.

Until October 2017, BOTOX^® was also approved for two cosmetic uses: glabellar lines between the eyebrows and lateral canthal lines, better known as crow’s feet. The newest cosmetic approval is for forehead lines.

Anyone familiar with BOTOX^® Cosmetic will know that it’s frequently applied elsewhere. Some of the most common uses include relaxing platysmal bands to tone down the prominence of cords on the throat, smoothing out “bunny lines” that appear when wrinkling the nose, reducing the amount of pink visible above the teeth in an overly “gummy smile,” addressing vertical lip lines, making chin dimples less visible, keeping the corners of the mouth from turning down too much, and preventing eyebrows from creating a permanent scowl.

These are all known as “off-label” uses, since the treatments don’t appear in the official marketing materials for BOTOX^® Cosmetic. An FDA approval is key to that: It determines which indications can be used in marketing across state lines throughout the country.

Off-label uses of known medications are common, and may even eventually lead to new FDA approvals. Some off-label applications are under review in trials, as was the case with BOTOX^® Cosmetic for forehead lines. Many dermatologists and plastic surgeons who offered the injectable have noted for years that it could be used for temporarily relaxing the frontalis muscle.

That said, an FDA approval does give the treatment in question more weight—supported by an increase in official marketing efforts alone. Allergan’s recent press release noted that BOTOX^® Cosmetic is now the sole neurotoxin in the world approved for three facial treatment areas. In the United States, it’s the only brand of neuromodulator that has received approvals for more cosmetic indications than glabellar lines.

The study leading to the forehead-line approval focused on patient selection, dosing, and pattern injection, all with an eye for optimizing outcomes. The FDA green light in effect sets the recommended guidelines for this particular treatment, which can guide other medical professionals who provide the product to their patients.

The clinical trials revealed that BOTOX^® Cosmetic generated results far more noticeable than those generated by the placebo—a change marked at 30 days by both the investigator and the subjects. While none of the first study’s participants and only 1 percent of the second study’s participants treated with a placebo met what’s known as “the primary endpoint” after a month, the subjects who received actual BOTOX^® Cosmetic noticed a more significant change: 61 percent in the first study and 46 percent in the second.

Find out more about BOTOX^® from South Carolina’s Germain Dermatology, where board-certified dermatologists administer the injections. Send a message online or call 843.881.4440.