Evaluation of the clinical safety and efficacy of a noninvasive dual-frequency monopolar radiofrequency device in the treatment of facial photoaging sequelae in Republic of Korea: a clinical study
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Background: Monopolar radiofrequency (RF) has been extensively used as a valuable modality for noninvasive skin tightening and rejuvenation but is associated with side effects such as pain. In addition, the results have also been inconsistent. The present study sought to assess the safety and efficacy of a new-generation dualfrequency monopolar RF system for the treatment of facial laxity with fine lines and wrinkles. Methods: Twenty female subjects aged 28-63 years with Fitzpatrick skin types III and IV and mild-to-moderate skin aging underwent a single treatment with the monopolar RF system at dual frequencies of 6.78 and 2.0 MHz. Pain during treatment was scored on a visual analogue scale (VAS). The final assessment was performed 12 weeks after treatment. Two independent, blinded investigators identified correct post-treatment photographs and scored improvement using a Global Aesthetic Improvement Scale (GAIS). Patients assessed satisfaction subjectively on a VAS. The occurrence of unexpected adverse events during treatment or follow-up was investigated. Results: All 20 patients completed the treatment, follow-up, and final assessment. Independent investigators successfully identified post-treatment images in 80% of cases, and their GAIS score averaged 2.75 out of 4. All patients scored at least 7 out of 10 for satisfaction, and pain was scored as mild to moderate. No adverse events were recorded. Conclusion: The good GAIS scores by independent clinicians, high patient satisfaction levels, and mild-tomoderate pain scores indicated the dual-frequency monopolar RF system was effective in treating aging facial skin, while safety was supported by the lack of unexpected adverse events.
Abstract
Background: Monopolar radiofrequency (RF) has been extensively used as a valuable modality for noninvasive skin tightening and rejuvenation but is associated with side effects such as pain. In addition, the results have also been inconsistent. The present study sought to assess the safety and efficacy of a new-generation dualfrequency monopolar RF system for the treatment of facial laxity with fine lines and wrinkles. Methods: Twenty female subjects aged 28-63 years with Fitzpatrick skin types III and IV and mild-to-moderate skin aging underwent a single treatment with the monopolar RF system at dual frequencies of 6.78 and 2.0 MHz. Pain during treatment was scored on a visual analogue scale (VAS). The final assessment was performed 12 weeks after treatment. Two independent, blinded investigators identified correct post-treatment photographs and scored improvement using a Global Aesthetic Improvement Scale (GAIS). Patients assessed satisfaction subjectively on a VAS. The occurrence of unexpected adverse events during treatment or follow-up was investigated. Results: All 20 patients completed the treatment, follow-up, and final assessment. Independent investigators successfully identified post-treatment images in 80% of cases, and their GAIS score averaged 2.75 out of 4. All patients scored at least 7 out of 10 for satisfaction, and pain was scored as mild to moderate. No adverse events were recorded. Conclusion: The good GAIS scores by independent clinicians, high patient satisfaction levels, and mild-tomoderate pain scores indicated the dual-frequency monopolar RF system was effective in treating aging facial skin, while safety was supported by the lack of unexpected adverse events.