Thank you for visiting Dr. D.J. Verret of Innovations Facial Plastic Surgery & Wellness Center. Dr. Verret is a facial plastic surgeon in the North Dallas suburb of Plano, TX. Rather than delegate injectibles to other non-physician members of his practice, Dr. Verret personally performs all of the Botox Cosmetic® and facial filler procedures that his patients undergo.

How It Works

Botulinum toxin is part of a class of medications referred to as neuromodulators. Botulinum toxin works by inhibiting release of acytelcholine from motor neuron end plates. Muscle activity is controlled by motor neurons, or motor nerves, which talk to the muscle by releasing chemicals between the end of the nerve and part of the muscle. The major chemical in voluntary muscles which is used to communicate is acetylcholine. By blocking acetylcholine, activation of muscles is prevented. Botulinum toxin is a protein made by a bacteria, clostridium botulinum, the same bacteria responsible for botulism.  Seven proteins have been discovered that are made by the bacteria and are named A-G.

Currently Approved Medications

Currently in the United States there are two formulations of the protein which are available for medical use – Botulinum toxin A and Botulinum toxin B. Botulinum toxin A is marketed under the trade names Botox® and Botox® Cosmetic by Allergan corporation and Botulinum toxin B is marketed under the trade name Myobloc® by Solstice Neurosciences. Botulinum toxin type B is less potent and shorter-acting than botulinum toxin type A.
Botulinum toxin type B was FDA-approved December 8, 2000 for the treatment of cervical dystonia in adults. Botulinum toxin type A was first approved by the FDA in December 1989. Today, Allergan corporation markets its botulinum toxin type A under two separate trade names Botox  and Botox Cosmetic.  The products are exactly the same except for their indication from the US FDA. The FDA has approved Botox® Cosmetic ‘for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients < 65 years of age.’ The glabellar lines are the lines between the brows. Botox is indicated for use in cervical dystonia (neck muscle spasms), strabisumus (cross eyes), blepharospasm (involuntary eyelid twitching), and primary axillary hyperhidrosis (excess armpit sweating). While these are the only indications for Botox the medication is used in other areas of the body to treat similar conditions. Any treatment outside of these indications is considered off-label by the FDA and should be presented to the patient as such. Off label uses are uses for which scientific studies demonstrating safety and efficacy have not been presented to the FDA. For instance, use of Botox® Cosmetic in the crow’s feet area (the area around the outside corner of the eye) is an off label use. This is very safe and has proven effective in multiple scientific studies, though Allergan has chosen not to apply to the FDA for this indication. Advertising for a product can only indicate the FDA approved uses. In this case, Allergan cannot promote Botox® as being able to improve lines around the outside of the eye in the crow’s feet area.

Medications Awaiting Approval

Currently there are two companies working to bring other botulinum type A formulations to market. Mentor Corporation is currently conducting Stage 3 clinical trials of its formulation trade name PurTox®.  Medicis Corporation and Ipsen have submitted an application for approval of their botulinum toxin type A trade name Reloxin® and Dysport® to the USA FDA in March 2008. The medication is currently approved for use in 21 countries around the world.

Current Cosmetic Uses

The only formulation of botulinum toxin currently approved for cosmetic uses is Botox Cosmetic® and it is only indicated for use in glabellar furrows, the lines between the eyebrows. In April of 2004, a panel of experts in the administration of Botox for cosmetic purposes was convened and established a set of recommendations for cosmetic Botox use which was published in a November 2004 supplement to the Plastic and Reconstructive Surgery journal.  Areas for which recommendations were made included glabellar lines, horizontal forehead lines, “crow’s feet,” “bunny lines” (downward radiating lines on the sides of nose), the area around the mouth, the dimpled chin, and platysmal bands. 
Care must be taken when using botulinum toxin as it can spread from the injected area and any muscle groups encountered will be paralyzed. In the glabellar area, care must be taken during injection not to inject too close to the eye socket as travel can result in a lax upper eyelid. Injection in the platysma of the neck can result in difficulty swallowing. Botox injected into the lips can result in changes in speech and in the worst cases, drooling. People with jobs that are especially sensitive to speech such as speakers, news anchors, singers, and commentators will be best served by avoiding botulinum toxin injections into the lips.

Side Effects

According to Allergan, Botox® Cosmetic should not be used in patients who have an infection where BOTOX® Cosmetic will be injected, are allergic to any of the ingredients in BOTOX® Cosmetic , are pregnant or think you might be pregnant. Caution should be used in patients with any diseases that affect the nerves or muscles such as ALS, Lambert Eaton syndrome, myasthenia gravis, and others; are breast feeding; or are thing about becoming pregnant. Botox can interact with certain medications including some antibiotics, medications used to treat heart arrhythmias, and some medications used to treat neurologic conditions. The most common side effects following injection include temporary eyelid droop and nausea. Localized pain, infection, inflammation, tenderness, swelling, redness, and/or bleeding/bruising may be associated with the injection.

Treatment

Injection of Botox® Cosmetic is fairly straight forward. There is generally a small amount of pain associated with injection but this can be improved with either topical numbing medicine or ice. Botox® cosmetic is supplied to physicians as a dry power which must be reconstituted. Depending on the dilution used by the physician, a similar number of units may be injected in varying volume of liquid. To ensure that there is a common expression of amount injected, Botox® injections are measured in units. The number of units needed to paralyze a certain area varies by patient. Typical starting dose for treatment of the glabella is 20 units.

Results

Effects will usually be seen in 2-3 days though it may take 1-2 weeks before maximum effect is seen. In some patients, antibodies may develop to the botulinum protein. In these cases, increasing doses of the protein are needed to get the desired effect and in rare instances, patients may no longer respond at all.
Botox is said to last for approximately 3 months, though individual results will vary. For patients who undergo regular Botox Cosmetic injections, a disuse atrophy of the muscles is seen and the effect of Botox® can last significantly longer than 3 months. This phenomenon is similar to that seen in other muscles when working out on a regular basis. When a person stops working out, the muscles will wither. Muscles treated by botulinum toxin will necessarily not work and will become less strong. Even though the protein has worn off, the effect of skin wrinkling may not be seen because the muscles are not strong enough. If the muscles are treated again at the first sign of activity, they will be weakened even farther allowing the effect to be seen a longer period of time.

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