Evaluation of the Efficacy and Safety of Microfocused Ultrasound Combined with 1550-nm Non-Ablative Fractional Laser for Facial Rejuvenation in Asian Patients with Fitzpatrick Skin Types III-IV: A Prospective, Randomized Split-Face, Controlled Trial.

BACKGROUND: Facial aging involves deep structural changes and superficial skin texture alterations, single-energy treatments often fail to address both dermal remodeling and skin rejuvenation comprehensively, and combination regimens may enhance outcomes by targeting complementary layers. This study aimed to evaluate the efficacy and safety of microfocused ultrasound (MFU) combined with 1550-nm non-ablative fractional laser (NAFL) in facial rejuvenation for Asian patients with Fitzpatrick skin types III-IV. OBJECTIVES: To assess the efficacy and safety of MFU combined with 1550-nm NAFL in improving facial laxity, wrinkles, and pigmentation. METHODS: A prospective, randomized, evaluator-blinded, split-face study was conducted with 22 participants (44 facial sides) with facial photoaging. MFU was applied to both sides, with one side followed by 1550-nm NAFL. Two therapy sessions with a 6-week interval were held. Evaluations were conducted at baseline, 6, 12, and 24 weeks, using biometric and ultrasound measurements to assess treatment efficacy. Safety was assessed based on adverse events (AEs). RESULTS: All enrolled participants presented with Fitzpatrick skin types III-IV, and 22 participants completed the 24-week follow-up. Compared to baseline, both sides showed significant improvements in IASLSS, FWS, PIS, dermal thickness, skin relaxation time, MI, and EI (all P < 0.05). Between-side analysis demonstrated that the combined side had greater benefits than the MFU side in improving FWS, PIS, dermal thickness, skin relaxation time, and MI (all P < 0.05), with no significant difference in IASLSS and EI (both P > 0.05). CONCLUSIONS: MFU combined with 1550-nm NAFL is effective and safe for facial rejuvenation. The combined therapy provides superior improvement in facial wrinkles, pigmentation, and patient satisfaction rates. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .