Clinical Efficacy and Safety of a Monopolar Radiofrequency Device With Comfort Pulse Technology for the Treatment of Facial and Neck Laxity in Men.

The objective of this study was to demonstrate the efficacy and safety of a monopolar radiofrequency treatment for facial and neck laxity in men. Twelve men received one treatment of the face and upper portion of the neck using an RF system with comfort pulsed technology. Standardized photographs were taken at baseline and at 1, 3, and 6 months of follow-up. Study investigators evaluated facial and neck laxity at baseline and all follow-up visits using the Fasil Laxity Scale. Patents and investigators assessed skin texture and overall appearance using the Quartile Improvement Scale. Average improvement in treated areas was statistically significant at 1-month (P<.01), 3-month (P=.02), and 6-month (P=.05) follow-up visits compared with baseline. Investigators rated greatest improvement in skin texture and overall appearance (mild to moderate) at the 3-month follow-up. Patient assessments demonstrated moderate improvement in skin laxity, skin texture, and overall appearance maintained out to 6 months after treatment. A total of 64% of patients were satisfied to very satisfied with treatment at the 6-month follow-up. One RF treatment of the face and neck yielded 20% reduction in facial laxity 1 month after treatment, with maintained improvement out to 6 months (15% reduction).