Cryoneuromodulation (Focused Cold Therapy™)

Focused Cold Therapy™, generically known as cryoneuromodulation is a new non-invasive treatment designed to improve the appearance of fine lines and facial wrinkles using highly pressurised nitrous oxide. Specifically targeted towards patients who are uncomfortable with the idea of using botulinum toxins (e.g., Botox) to smooth out wrinkles, cryoneuromodulation is essentially a toxin-free way that is being marketed to achieve a wrinkle-free appearance in the forehead and frown areas, utilising the power of cold, rather than the power of a neurotoxin. Currently, there is only one cryoneuromodulation product being actively marketed for this type of treatment, called Iovera® and made by Myoscience Inc, who have patented the therapy and trademarked the concept of Focused Cold Therapy™. Focused Cold Therapy™ with Iovera® costs approximately £300 for a 15 minute session. The treatment is in its early stages of use and is not currently widely available in the UK.

Background

Cryoneuromodulation Background Information

Focused Cold Therapy™, generically known as cryoneuromodulation is a brand new non-invasive treatment designed to improve the appearance of fine lines and facial wrinkles using highly pressurised nitrous oxide (commonly known as laughing gas). 

Specifically targeted towards patients who are uncomfortable with the idea of using botulinum toxins to smooth out wrinkles, cryoneuromodulation is essentially a toxin-free way that is being marketed to achieve a wrinkle-free appearance, utilising the power of cold, rather than the power of a neurotoxin. 

Currently, there is only one cryoneuromodulation product being actively marketed for this type of treatment, called Iovera® and made by

 Myoscience Inc, who have patented the therapy and trademarked the concept of Focused Cold Therapy™.

 Although the use of cold therapy in cosmetic treatments is relatively new, cold therapy has been used in general surgery and in general patient care for a number of years. 

Cryoneuromodulation is not a permanent solution to treating wrinkles, as the effects last for about three months, but with repeated procedures in conjunction with other wrinkle treatments, you can expect fewer wrinkles and a smoother complexion in the long-term it is said. 

The therapy has had some clinical success too, although trial data is currently limited. 100% of patients and investigators in two clinical studies reported an improvement in the severity of dynamic facial lines and wrinkles immediately following treatment. 

The treatment is most often used to treat forehead lines as well as the frown lines between the brow, with the cold therapy being focused at the nerves on the forehead that control the muscles responsible for wrinkles and fine lines. The treatment effectively numbs the nerves, sending them into “hibernation” for up to three months.  With the nerves numbed, muscles can relax and wrinkles soften and disappear.

If you are considering cryoneuromodulation, the following information should give you a basic understanding of the procedure. It can’t answer all of your questions, as the outcome of the procedure depends on the individual person and practitioner. Please ask a cosmetic practitioner about anything you don’t understand.

Types

What are the different types of Cryoneuromodulation available?

There is currently only one device being marketed for cryoneuromodulation using the patented mechanism of Focused Cold Therapy™ which is Iovera® created by Myoscience.

The device was approved in Europe for a CE Mark in January 2013. It has been approved by the U.S. FDA for the treatment of peripheral nerve.

The Iovera device features a patented Smart Tip, which houses 3 closed-tipped needles used to deliver thenitrous oxide during the treatment, aswell as an integral skin warmer within the device designed to keep the patient's skin at an ambient and comfortable temperature. tissue for the blocking of pain, a more medical application. Further applications are being made to gain approval for cosmetic uses.

What Is It?

What is Focused Cold Therapy?

Focused Cold Therapy™ using the Iovera® device from MyoScience is a new minimally invasive treatment designed to smooth away fine lines and wrinkles on the forehead and those between the brow; the glabellar. 

Referred to as ‘Cold tox’ or ‘Frotox’ by the media, Focused Cold Therapy uses focused cold nitrous oxide to ‘numb’ nerves in the forehead, relaxing the muscles which cause wrinkles and creating a smoother appearance. 

The major benefit of using cryoneuromodulation is that you can see immediate results, with no foreign chemicals or substances left behind in the body. Botulinum toxins can take up to four days to work, so Focused Cold Therapy could be a great alternative for those seeking more immediate results, and because the facial nerves are effectively numbed for up to 3 - 4 months, you will see results that are comparable with toxins and relatively long-lasting when compared to the temporary wrinkle-free appearance offered by skin creams. 

Focused Cold Therapy works by causing a neural conduction block by inducing second degree Wallerian degeneration (a process that occurs when a nerve fibre is cut or crushed). Regeneration of the nerve cells begins within 24 hours. The therapy targets the temporal branch of the facial nerve, in turn innervating (relaxing) the elevator and the depressor muscles in the forehead, lessening the appearance of wrinkles in the area.

Following treatment, the nerves undergo a period of dormancy or effective hibernation, which is followed by a complete restoration of function as the connections regrow.

What Can It Treat?

What can Focused Cold Therapy treat?

Because Focused Cold Therapy using Iovera is a relatively new procedure, it is still only being targeted to treat a small and specific area of the face.

It can treat fine lines and wrinkles on the forehead and the frown lines between the brows, as the entry points are the nerves close to the temples. You can expect to see a reduction in the severity of vertical and horizontal dynamic lines and wrinkles on the forehead and between the brows immediately after treatment, with the results lasting for up to 3 - 4 months.

There are some people who require more treatment sessions or more applications within a treatment session to fully deactivate their nerves to achieve the desired results, and for a small percentage of people the treatment has been shown not to work at all, the so call non-responders.

Treatment

What happens during a Cryoneuromodulation treatment?

Careful discussions regarding your reasons for wanting this treatment, in lieu of other treatment options available, are very important before you begin the treatment. You must also make sure that this treatment can deliver what you want and how you would like to look afterwards. Your practitioner should be able to answer all these questions.

A medical history should also be taken to make sure that there are no reasons why you shouldn’t undertake treatment. You may be asked to sign a consent form which means that you have understood the potential benefits and risks associated with the procedure.

Photographs may also be taken by the practitioner for a "before and after" comparison at a later date.

This information refers to what to expect from a Focused Cold Therapy™ treatment with the Iovera® device.

Treatment sessions are short, taking around 15 minutes for one treatment. 

The practitioner will begin by thoroughly cleansing the face. A TENS (Transcutaneous Electrical Nerve Stimulation) machine, similar to those used for back pain relief etc. will be used to actively map out the facial nerves, on application of the TENS device, the nerves in the face twitch which allows correct location. The application points for treatment can then be marked on the face. 

Local anaesthetic will then be injected into the skin to numb the area where the device will be applied and then the treatment can begin. 

The Iovera device has closed-tip needles at the end of the hand piece, within a single person use ‘Smart Tip’, which are inserted into the skin at the marked application points in the path of the nerve. To deactivate the nerve by chilling it, liquid nitrogen is passed into these needles when the hand piece is turned on (it doesn’t go into the skin as the needles are closed-tipped). At the needle tip, the liquid nitrogen turns into a gaseous form, nitrous oxide which draws in heat from the surrounding skin, creating a very precise zone of cold. Each cycle of application lasts 60 seconds.

Those treated are said to experience the feeling of pressure at the injection site rather than cold, although some do report that it is a tolerable pain. Once the procedure is over, the practitioner may offer topical cream to soothe any redness around the sites of the injections and you will be free to go about the rest of your day. 

Recovery

How long will it take to recover from a Focused Cold Therapy treatment?

Because cryoneuromodulation is minimally invasive, there is no recovery time associated with the procedure.

Side Effects and Risks

What are the risks and potential complications from Cryoneuromodulation treatment?

The most commonly reported side effects from cryoneuromodulation with Iovera during clinical trials included swelling at the injection sites, redness, inflammation, pain and tenderness at the application points, cold and hot injury and bruising to the face.

Within a few days, these side effects should disappear. 

Post-Treatment Advice

What should you do after a Focused Cold Therapy treatment?

It is important to follow any post-treatment advice given to you by your practitioner, this may include:

Clean the treated areas gently in the days following the procedure

Avoid using heavy makeup or products on the treated areas, particularly if you are experiencing tenderness or redness. 

If you experience localised pain or swelling which do not disappear within the first few days, you might want to use an anti-inflammatory painkiller such as Ibuprofen to lessen the pain and reduce swelling.

Contra-indications

Who should not have a Cryoneuromodulation treatment?

Cryoneuromodulation or Focused Cold Therapy™ is a minimally invasive procedure and so it is suitable for most people in general good health and with reasonable expectations of the outcome of the procedure.

It may not be as effective at treating very deep wrinkles or even very fine wrinkles.  A trained practitioner will be able to tell you whether you are a good candidate for this type of procedure or whether you would benefit from another treatment option or a combination of treatment types.

There are reported cases of non-responders where cryoneuromodulation simply doesn’t deactivate nerves successfully enough to relax the muscles which cause the wrinkles.

Who Can Do It?

Who can perform a Cryoneuromodulation treatment?

Only fully trained and qualified cosmetic doctors and plastic surgeons can perform a cryoneuromodulation procedure. (Currently nurses are not being trained by Myoscience to deliver treatment with the Iovera device.)

For more information about practitioner training, qualifications and relevant medical organisations please view the information contained within the Legislation section of the Consulting Room.

Price

What is the average cost of Cryoneuromodulation treatment?

The treatment of cryoneuromodulation for wrinkle reduction is still very new and not yet widely available. The cost of treatment will depend on many things including the practitioner and the number of sessions required (if more than one). Focused Cold Therapy™ with Iovera® costs approximately £300 for a 15 minute session. 

Conclusion

Summary of advice for Focused Cold Therapy treatment

Focused Cold Therapy™ or cryoneuromodulation is a new, minimally invasive alternative to procedures such as Botox for the treatment of lines and wrinkles on the forehead and between the brows. 

The treatment is in its early stages of use and is not currently widely available in the UK. 

There is also limited clinical data for its cosmetic applications and some clinicians have noted that it may not provide them with the ‘fine tuning’ of an overall aesthetic result which they are able to achieve with the more dose dependent treatment that toxins offer, where they can add a little here and there to ‘shape’ the face and reduce wrinkles.  

More comparative clinical trials need to be performed to ascertain its effectiveness in comparison to neurotoxins, but there is no debate needed on that fact that it does provide an alternative solution for those who simply don’t like the idea of injecting a botulinum toxin into their body. With no chemicals or drugs injected with Focused Cold Therapy™, aside from the local anaesthetic (lidocaine), this may well become an everyday alternative as we go into the future.

It is worth noting that although this treatment is marketed at toxin-free, it is not needle-free as the Iovera® hand piece uses closed tipped needles which are injected into the skin to deliver the cold therapy.