Reduction of Facial Rhytids Through Selective Cryoneuromodulation

Goals/Purpose: Dynamic facial wrinkles are commonly being treated with neurotoxins and fillers.  Risks and adverse side effects associated with the improper delivery of neurotoxins, and diminished clinical benefits of fillers due to uncontrolled diffusion present the need for more a more efficacious treatment modality.   A novel minimally invasive technology has been developed to reduce muscle movement involved in the creation of dynamic wrinkles.   A cryoprobe device has been developed to soften facial wrinkles through inhibition of nerve conduction to target facial muscle groups.  We will present the current findings of an ongoing clinical trial that evaluates the efficacy and safety of this procedure.

Methods/Technique: A prospective clinical study is underway to evaluate the investigational low temperature device (MyoScience, Inc., Redwood City, CA) for the treatment of frontalis dynamic wrinkles.  The investigational device consists of a trident probe, delivered subcutaneously and cooling activated for 30 seconds, and followed by 15 seconds of thawing time before the device is removed from the treatment sites.  Wrinkles were assessed using  a 5-point wrinkle severity scale for the forehead and a 4-point severity scale for the glabella at baseline, immediately post treatment, 1-, 7-, 30-, 60-, 90-, and 120-days post-treatment.  Photographic documentation of change in wrinkle severity was captured at the same time points.  The primary endpoint was a reduction in line severity in animation as rated by the investigator.  The duration of treatment effect and adverse event rates were also evaluated.

Results/Complications: To date, 20 patients were enrolled and treated with the device.   100% of patients showed immediate reduction in dynamic wrinkle post-treatment.  75% of patients showed continued 1 point reduction in wrinkle severity at 30 days post-treatment, 50% continued to have a positive response at 60 days.  75% of subjects felt their global appearance had improved by 25% at 30 days.  Minimal local site reactions were reported and no severe adverse events has occurred during this trial. These patients will continue to be followed out to 120 days.

Conclusion: The novel cryoprobe device enabled delivery of a targeted treatment to the temporal branch of the facial nerve.  This study demonstrated immediate reduction of muscle movement with response lasting a minimum of 30 days, with longer duration in most patients.  A lack of serious adverse events demonstrates the safety profile of this technology.