Muscle Relaxant (Xeomin ®)
Generic name of Xeomin®
Clostridium botulinum type - A neurotoxin complex.
Also known as NT-201, botulinum neurotoxin free from complexing proteins
Product Summary
Launched in the UK in 2008, Xeomin® is the third botulinum toxin type A to be promoted in the UK. Xeomin® claims to be an innovative Botulinum type A formulation, in which the complexing proteins have been removed by an extensive purification process from the botulinum toxin complex. In contrast to the other commercially available preparations, Xeomin® contains the pure 150 kD neurotoxin.
It is widely accepted that the bacterial protein present in other products play a role as promoters of an immune reaction, resulting in a loss of effect and reduction in duration of activity. Studies show that Xeomin®, without the complexing proteins, has the lowest content of protein of all of the available botulinum toxins and furthermore show that repeated application of Xeomin®, even in high doses, does not induce the formation of neutralising anti-bodies.
This means that Xeomin® is able to provide similar results to those achievable with the other products without the risk of antibody formation, providing continual long lasting effects. This could be relevant when large doses are being used for medical indications, but many industry experts question the relevance when this product is used for cosmetic purposes.
How is it manufactured?
Xeomin® is made from purified type - A neurotoxin produced by the bacteria Clostridium botulinum with complexing proteins removed through purification.
How does it work?
Our facial expressions change because the muscles in the face contract or relax. This is caused by the brain sending a signal via our nerve endings that we want to, for example, frown or laugh. When botulinum toxin is injected into a specific muscle it blocks the signal from the nerve to the muscles in the face. This means that the nerve ending cannot tell the muscle to move. This is not a permanent condition, however, but it will last for around 3 - 4 months.
After botulinum toxin injections, your skin around the area which has been treated will look smooth and less wrinkled; but do not worry, the rest of your face will not be affected. Botulinum toxin allows the untreated areas of your face to move as normal and you will still be able to laugh, smile and frown, but with less wrinkling of the skin in the areas treated.
After a while, most patients will notice that the lines and wrinkles around their treated areas will continue to become less deep and pronounced. This is a result of the botulinum toxin as the new skin has a chance to grow without being repeatedly creased. Hence, it appears to be smoother on the surface because it has not been creased by constant muscle activity.
The history of Botulinum Toxin
It may surprise you to know that botulinum toxin, or Botox® as we commonly now call it, has a history stretching back almost two hundred years. In 1822, a German doctor named Justinius Kerner, suggested that botulinum toxin injections might be used in the treatment of excessive sweating or hyperhidrosis. Botox® is now regularly used for this condition.
By the late 1960s, Botox® had begun to be used in American clinics for the treatment of squints (strabismus).
Its use in treatment of the eyes was pioneered by an American called Alan Scott. Twenty years later, the real breakthrough came in the wider application of Botox® when Allergan, the American manufacturer of Botox®, was granted approval to market the drug by the Federal Drugs Agency. This gave Allergan the license to sell its new product throughout the U.S. Since then, Botox® has been registered and used in over 90 countries around the world, and other versions of botulinum toxin are also available in the UK, namely Dysport®, Xeomin® and Neurobloc®.
The next significant development in knowledge about botulinum toxin came in 1987 via a Canadian Ophthalmologist, Dr. Jean Carruthers. She had been treating her patients who suffered from blepharospasm with Botox®. Dr. Carruthers observed that a "side-effect" of this treatment was the reduction of crow's feet and wrinkles around the eyes. She then decided to test these findings scientifically, and she and her husband, a Consultant Dermatologist, (skin specialist) devised clinical trials to monitor the effectiveness of this treatment.
Since then, an enormous amount of clinical trial work and patient experience has been established using Botox® for the treatment of wrinkles, and in 2009, The American Society for Aesthetic Plastic Surgery rated treatment with botulinum toxin the most popular aesthetic procedure in the U.S..
A staggering 2.43 million Americans had a Botox® treatment in 2010, a decrease of 4.7% on 2009 figures. This represents 26% of all cosmetic treatments in the U.S. in that year.
Although there are as yet no similar detailed statistics available for the United Kingdom, it is likely that Botox® is also the number one procedure here.
Botox® is now licensed by the regulatory authorities in the U.S., as well as more than a dozen other countries around the world, for the treatment of glabellar lines and wrinkles.
In March 2006, Vistabel®, the brand name used for Botox® with a dosing specific to treat glabellar lines was granted a licence in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA) for the "temporary improvement in the appearance of moderate to severe glabellar lines (vertical 'frown' lines between the eyebrows) in adult women and men aged 65 and younger, when the severity of these lines has a psychological impact for the patient".
The same licence was granted to Dysport®, under the brand name Azzalure® in March 2009.
However, if you are considering having a botulinum toxin treatment in this country, the above is nothing to be alarmed about. U.K. practitioners can use any of the other brands available, however they should make you aware that they are using them outside of their current U.K. licensed indications.
Science has discovered many other clinical uses for botulinum toxin including spasticity in adults and children, back pain, tension headache, migraine, dystonia, (spasm of the limbs) and anal fissure (tearing in the skin of the anus) which have all been treated successfully with this important product.
If you are considering treatment with botulinum toxin, the following information will give you a basic understanding of the procedure. It can't answer all your questions, since a lot depends on the individual patient.
Please ask a practitioner about anything you don't understand.
What is Botulinum Toxin?
Botulinum toxin is a naturally occurring protein produced by the bacterium Clostridium botulinum. This bacterium makes several different types of protein which are called type A to type F. These varying proteins cause muscles to relax at different levels.
There are currently two different types of botulinum toxin commercially available in the United Kingdom – type A toxin (including the brands Botox®, Vistabel®, Dysport® , Azzalure® and Xeomin® and Bocouture®) and type B toxin (Neurobloc®).
How does Botulinum Toxin work?
Our facial expressions change because the muscles in the face contract or relax. This is caused by the brain sending a signal via our nerve endings that we want to, for example, frown or laugh. When botulinum toxin is injected into a specific muscle it blocks the signal from the nerve to the muscles in the face. This means that the nerve ending cannot tell the muscle to move. This is not a permanent condition, however, but it will last for around 3 - 4 months.
After botulinum toxin injections, your skin around the area which has been treated will look smooth and less wrinkled; but do not worry, the rest of your face will not be affected. Botulinum toxin allows the untreated areas of your face to move as normal and you will still be able to laugh, smile and frown, but with less wrinkling of the skin in the areas treated.
After a while, most patients will notice that the lines and wrinkles around their treated areas will continue to become less deep and pronounced. This is a result of the botulinum toxin as the new skin has a chance to grow without being repeatedly creased. Hence, it appears to be smoother on the surface because it has not been creased by constant muscle activity.
Botulinum toxin can be used to treat all wrinkles which are the result of normal facial movement. It is not suitable for permanent wrinkles caused by excessive exposure to the sun.
Botulinum toxin does not remove wrinkles indefinitely; it is usually necessary to have a treatment every 3 - 4 months to maintain and improve upon the original results. It has been proven to be quite safe to have botulinum toxin injections at the above frequency over a period of years.
Licenced status
Prescription only medicine
Who can perform Xeomin® treatments?
It should be used by trained members of the medical profession only.
Owing to the popularity of botulinum toxin, you can find this treatment available in a wide variety of settings and being offered by practitioners as varied as dentists, plastic surgeons, general surgeons, dermatologists, (skin specialists) general practitioners, gynaecologists, ophthalmologists (eye specialists), cosmetic doctors and nurses.
Beauticians, beauty therapists and other non-medics are not allowed to inject botulinum toxin as it is a Prescription Only Medicine (POM).
Nurses are allowed to inject botulinum toxin (acting under a prescriber's instruction), but you should have seen a doctor, dentist or independent nurse prescriber first to ensure your suitability for treatment.
Licenced UK indications for Xeomin®
Xeomin® is licenced in the UK for blepharospasm and cervical dystonia. It also gain approval for cosmetic use in 2010 under the brand nameBocouture®.
Who should not have Xeomin® treatment?
Individuals with a known hypersensitivity to any component of the formulation.
Patients who have generalised disorders of muscle activity (e.g. myasthenia gravis).
Patients where aminoglycoside antibiotics or spectinomycin are already being used or are likely to be used.
Patients who have bleeding disorders of any type.
Pregnant or lactating women.
Reported side effects associated with the cosmetic use of Xeomin® include
Most patients find that Botox® injections cause little discomfort. Many compare the feeling to a little insect bite! As the treatment is very quick, the needles used are tiny and only minute amounts of liquid are being injected into the skin; few patients experience any significant pain.
A few patients do, however, prefer to have an aesthetic cream applied half an hour or so prior to treatment to help numb the skin.
Other risks or side effects include a small amount of temporary bleeding or mild swelling which may occur at the injection site. In some cases more extensive bruising may occur, especially around the eyes, but this can usually be covered up with make-up, and is only temporary.
Occasionally, patients experience a headache after treatment, and, very rarely, double vision.
When botulinum toxin is injected into the forehead area, there is a very slight possibility that it may cause weakness of the muscle holding up the eyelid causing a “partial ptosis” or drooping of the upper eyelid.
In experienced hands this tends to happen in less than 1% of patients and will disappear over a period of 2 - 10 weeks. Some doctors also use an eye drop called apraclonidine to help to speed up the recovery if this effect occurs.
If the forehead muscles are relaxed too much, especially in patients with looser skin, the treatment may cause the eyebrows to drop slightly. Again, this is only a temporary condition and will vanish usually within 10 weeks.
Sometimes, the eyebrow position may alter so that the edges of the eyebrows become elevated. Some women like this effect, but it is generally unwanted in men. It is easily corrected with a small amount of botulinum toxin injected above the raised area of the eyebrow to help change its position.
All patients should remember that because the results of botulinum toxin are not permanent, any unwanted effects will disappear usually within a 3 month period.
During 2003 there were some press reports claiming that Botox® may cause more wrinkles to appear. We have looked at these claims and can find no evidence in the scientific literature, at this point, to support these reports.
Costs
Most clinics and practitioners charge by area of the face treated. These areas are usually defined as crow’s feet, forehead lines, and glabellar lines (frown lines between the eyes).
Practitioners may charge from around£175 - £300 per treatment area.
A discounted rate is usually employed if more than one treatment is required, so that crow’s feet, forehead lines, and glabellar lines may cost £500 or less for the complete package.
Clinical Results
Most of the literature on Botulinum Toxin, and hence the clinical evidence and statistics, are based on Botox® as this brand represents around 80% of the world’s use of Botulinum Toxin.
Clinical studies have suggested that Xeomin® is similar in its effect to Botox®. 1 unit of Xeomin® is equal to 1 unit of Botox®
For more information:
www.consultingroom.com/Treatments/Botulinum-Toxin
