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

Background: Facial aging is determined by skin quality and the condition of underlying muscles, which contribute to the overall appearance by lifting heavy facial structures. Objective: 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. Methods: 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. Results: 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, p < 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. Conclusion: 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.