Novel Approach to Facial Rejuvenation by Treating Cutaneous and Soft Tissue for Wrinkles Reduction: First Experience from Multicenter Clinical Trial.

Facial aging is determined by skin quality and the condition of underlying muscles, which contribute to the overall appearance by lifting heavy facial structures. This study aims to assess the safety and effectiveness of the novel radiofrequency (RF) and high-intensity facial muscle stimulation (HIFES) technology for treating wrinkles by facial tissue remodeling. This trial assessed the 3-month data of 24 subjects seeking facial wrinkles treatment. All subjects received four treatments, with a device utilizing RF and HIFES. The evaluation included a two-dimensional photographs assessment according to the Fitzpatrick Wrinkle and Elastosis Scale (FWES) and a three-dimensional (3D) photograph analysis for facial appearance. Therapy comfort and subject satisfaction were assessed. Based on the data of 24 subjects (56.5 ± 2.0 years, skin types I-IV), the significant improvement increased up to 3 months (-2.3 points,  < 0.001) post-treatment. 3D photographs analysis documented notable cutaneous and structural rejuvenation and coincided with FWES evaluation, underlining the positive subjective appreciation of the results with 20.4% average wrinkle reduction at 1 month, further increasing to 36.6% wrinkle reduction at 3 months. Documented by both subjective and objective evaluation tools, the RF and HIFES procedure for facial rejuvenation was found to be effective for treatment of wrinkles and skin texture. ClinicalTrials.gov Identifier: NCT05519124.