Full article title: The efficacy of Focused Cold Therapy on horizontal dynamic forehead wrinkles: consecutive study from a single physician’s experience
Background: Traditionally, cryoneuromodulation can only be achieved with cryosurgery. However, the use of extreme low temperatures (approximately -180°C) could risk permanent damage to nerve function. Focused Cold Therapy (FCT) is a platform technology from the Silicon Valley-based medical technology company, myoscience, Inc (Redwood City, CA), and uses more moderate, yet effective, therapeutic temperature ranges to achieve cryoneuromodulation. FCT, delivered by the iovera° device, has been used in Europe to reduce dynamic facial wrinkles since April 2013. (In the US it is currently only used as a treatment for pain.)
Objectives: The present study investigates the efficacy of FCT, performed by a single physician, on horizontal dynamic forehead wrinkles.
Methods: Men and women aged 20–65 years with flat or concave temples and moderate to severe dynamic wrinkles in the forehead (at maximum raise of eyebrows) were treated with FCT using the iovera° device. Wrinkle severity was assessed using the Facial Wrinkle Scale (FWS), and physician-assessed scores before and after FCT were compared and analysed using the Wilcoxon Matched-Pairs Signed-Ranks Test. Additionally, subjects also assessed the change in dynamic wrinkle severity on a 9-point scale and rated their degree of satisfaction with the treatment on a 7-point scale.
Results: Twenty-five subjects aged 23–52 years participated in this study. The mean wrinkle score at maximum raise of eyebrows was reduced significantly by 2.24 after FCT (0.44 ± 0.6) when compared with before the treatment (2.68 ± 0.5) (P<0.0001). Twenty-four patients (96%) reported an improvement in horizontal dynamic forehead wrinkle severity immediately after the procedure. All patients were satisfied with the treatment.
Conclusions: FCT is an effective treatment option to reduce horizontal dynamic forehead wrinkles. This novel, non-toxin based approach produces immediate results with nothing left behind in the patient. The treatment itself is well-tolerated and yields a high satisfaction rate among patients.
The ideal aesthetic treatment, in the minds of the most demanding and savvy patients, would be one that not only improves appearance, but does not go against the preventative and anti-ageing health philosophies. In a world of organic food and free-trade cotton, it is only natural that there would be demand for health-conscious aesthetics.
The power of cold has been used in medical therapies for centuries before being adapted by modern medicine1. Local application of cold over a small range of temperatures (+10°C to -5°C) has been shown to produce a nerve conduction block that could last from a number of hours to days2,3. Traditionally, cryoneuromodulation could only be achieved with cryosurgery. However, despite its proven safety through decades of clinical use, cryosurgery involves the use of extremely low temperatures (approximately -180°C) that could risk permanent damage to nerve function4. With advancement in technology, cryoneuromodulation can now be achieved over more moderate, yet effective, therapeutic temperature ranges with Focused Cold Therapy (FCT). FCT was created by the Silicon Valley-based medical technology company, myoscience, Inc. (Redwood City, CA), and is delivered by their handheld device, iovera. With regard to its use in aesthetic medicine, we can now achieve temporary muscle relaxation and hence, dynamic wrinkle reduction, by blocking the impulse conduction of motor nerves without the use of neurotoxins. This revolution not only opens up a whole new ‘organic’ market in the aesthetic industry, but also offers an alternative to patients who are averse or resistant to the use of neurotoxins.
[pull_quote align=”right” ]The power of cold has been used in medical therapies for centuries before being adapted by modern medicine[/pull_quote]
Cosmetically speaking, FCT is the direct application of low temperatures to inhibit signalling of the temporal (motor) branches of the facial nerve in the temple region. The target rami of FCT are those which innervate the frontalis and corrugator muscles. When the target nerve is exposed to low temperatures between -20°C and -88.5°C, axonal and myelin degeneration occurs, inducing a second degree or Wallerian degeneration5. As the degeneration happens instantaneously, the cosmetic results can be seen immediately after the treatment. In contrast to more traumatic nerve injuries as a result of applying lower temperatures to the target nerve, FCT does not affect the acellular components of the nerve (i.e. endoneurium, perineurium, and epineurium), allowing normal axon regeneration and remyelination within 16 weeks6. An animal study carried out by Hsu et al4 further demonstrated that FCT does not cause any permanent or long-term changes to the function or structure of motor nerves.
FCT was commercially launched and has been used cosmetically in the UK since April 2013. Although FCT can reduce both the horizontal lines of the frontalis and the vertical frown lines of the forehead, this article will focus on its efficacy on the horizontal lines of the frontalis and present clinical data and feedback obtained from 25 patients who underwent the treatment.