The microneedle fractional radiofrequency system (MFRS) is able to rejuvenate facial appearance by heating and coagulating certain depth of skin tissue. To evaluate the safety and efficacy of a novel vacuum-assisted MFRS for facial contour tightening. This prospective, randomized, split-face study included 21 patients who underwent three treatments with a vacuum-assisted MFRS at 1-month intervals. Half of the face was treated with the MFRS; the other half was untreated (control). Facial volume changes and wrinkles were objectively measured using a three-dimensional imaging system and VISIA-CR. Volume changes of the treated midface were -0.24 ± 0.75, -0.59 ± 0.92, and -0.55 ± 0.65 mL at 1, 3, 6 months follow-up; however, measurements of the control side were 0.08 ± 0.70, -0.08 ± 0.53, and - 0.10 ± 0.86 mL, indicating significant reductions (p < 0.05). The number of facial wrinkles on the treated side was significantly reduced to 12.44 ± 4.85 at 3 months and sustained at 6 months (11.11 ± 4.100) compared to the control side (14.89 ± 5.26 and 13.22 ± 4.44, respectively; p < 0.05). No long-term side effects occurred. The vacuum-assisted MFRS is safe and effective and is recommended for improving facial tightening and reducing wrinkles. This technology is sufficient to ensure the insertion depth, thus helping to improve the treatment accuracy and safety. The MFRS provides sustained effects for at least 6 months.
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