Evaluation of efficacy and safety for the energy delivery and skin tightness of monopolar radiofrequency device in Asian.

Abstract

Monopolar radiofrequency(MRF) treatment is known to induce collagen contraction and remodeling in dermis. This study was conducted to evaluate safety of MRF in pre-clinical study first, and efficacy and safety in lifting and tightening of the face and upper neck in the clinical study. In pre-clinical setting, thermal imaging, and clinical and dermoscopic photography of after the procedure, and 7, 14, 30 days later were recorded. In clinical study, 23 subjects were enrolled and got 1 treatment. They were followed up at 4, 12, 24 weeks, and assessed using clinical photography. Changes in elasticity, pore number, wrinkle(%), and safety evaluation were also done. In the pre-clinical study, energy was safely delivered to the treatment area. In the clinical study, the clinical grades significantly decreased after 4, 12, and 24 weeks. Net and biological elasticity showed a significant increase at week 24. Pore count significantly decreased from week 12 and wrinkle started to decrease from week 4. Subjective satisfaction peaked in week 12. The average of pain score was 0.30 ± 0.63, and only mild adverse events were recorded. This study found that MRF deliver stable energy to the skin and have significant effect in skin laxity without complications.