The Evaluation of Efficacy and Safety of A Radiofrequency Hydro-Injector Device for the Skin around the Eye Area

In recent years, variable rejuvenation techniques, such as hyaluronic acid (HA) fillers and radiofrequency (RF) devices, have become popular. We evaluated the RF hydro-injector (RFHI) device that simultaneously delivers both a microneedle intradermal RF treatment and a HA filler injection to overcome the disadvantages of HA filler and RF devices alone. This study aimed to assess the efficacy and safety of the RFHI device for the rejuvenation of the periorbital area, including the lateral canthal lines (LCLs) and the infraorbital area. A total of 24 subjects were enrolled in this study and underwent 2 to 3 treatments using the RFHI device. The investigator's global assessment of the lateral canthal line (IGA-LCL) and the global esthetic improvement scale (GAIS) were used to evaluate the improvement in the LCL. Cutometer(R) was used to evaluate the skin's elasticity, and the Antera 3D image capture system(R) was used to evaluate the degree of wrinkles, roughness, and pore volume. At the 8 week follow-up after the first treatment session, both the IGA-LCL and GAIS showed significant improvement. The improvement in the wrinkles, roughness, and pore volume, measured by the Antera 3D image capture system(R), was statistically significant. No serious adverse event was reported. This RFHI device, which delivers both microneedle intradermal RF treatment and HA filler injection, is effective and safe for periorbital rejuvenation.

Automated summary

The study evaluated an RFHI device that delivers both microneedle intradermal RF treatment and HA filler injection for rejuvenating the periorbital area. Results showed significant improvement in both IGA-LCL and GAIS at the 8-week follow-up, as well as statistically significant improvement in wrinkles, roughness, and pore volume measured by the Antera 3D image capture system (R). No serious adverse events were reported, indicating that the RFHI device is effective and safe for periorbital rejuvenation.