Safety and effectiveness of focused cold therapy for the treatment of hyperdynamic forehead wrinkles.

BACKGROUND Approximately 25% of patients exploring treatments for wrinkle reduction, have reservations about toxins. Therefore, a nonsurgical, minimally invasive, and toxin-free approach to eliminate facial hyperdynamic lines is desirable. OBJECTIVE To assess the clinical safety and effectiveness of focused cold therapy (FCT) for the reduction of hyperdynamic forehead wrinkles. METHODS Forty-one subjects received FCT to temporal branches of the facial nerve. Hyperdynamic forehead wrinkles were assessed by the investigator and subject before treatment, immediately after procedure, and at 7, 30, 60, 90, and 120 days after treatment. A validated 5-point wrinkle scale and a 9-point global improvement scale were used to measure line severity. RESULTS Five subjects received a lower treatment dose and were therefore excluded from analysis. In the remaining 36 subjects, 91% had at least a 1-point improvement in forehead line severity at 30 days after treatment and 70% had at least a 2-point improvement. There were no serious adverse events. CONCLUSION Subjects treated for forehead wrinkles showed significant clinical improvement with high subject satisfaction and no serious adverse events. Focused cold therapy seems to be an effective, safe nontoxic alternative to popular wrinkle-reducing treatments.