A STUDY IN INTENSE FOCUSED ULTRASOUND, MICROFOCUS ULTRASOUND VERSUS MACROFOCUS ULTRASOUND IN THE EFFECT OF STATIC LINE AT CROW’S FEET, INFRAORBITAL LAXITY, INFRAORBITAL RHYTIDS: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLINDED, INTRAINDIVIDUAL SPLIT FACE STUDY

Abstract

This study aimed to compare the efficacy of high-intensity focused ultrasound (HIFU) using the Ultraformer III device with two different handpieces: the 1.5-mm microfocused transducer and the 2.0-mm macrofocused transducer, in the treatment of infraorbital laxity, crow’s feet, and under-eye wrinkles. The study was designed as a randomized split-face trial, with both evaluators and participants blinded to the allocation (evaluator- and subject-blinded randomized design). Twelve participants aged 35-60 years were enrolled, each receiving treatment on both sides of the face with different handpieces. Outcomes were evaluated at weeks 1, 6, and 12 after treatment using Visioscan® parameters combined with photographic analysis.The results demonstrated that both microfocused and macrofocused ultrasound significantly improved skin elasticity and reduced wrinkle scores, with changes ranging from 1-25% at weeks 6 and 12. No significant differences were observed in patient-reported satisfaction or pain levels during the procedure. Adverse events were limited to transient erythema, which occurred more frequently in the macrofocused group (33.3%) compared with the microfocused group (16.7%).In conclusion, both handpieces were effective in reducing infraorbital wrinkles and laxity; however, the microfocused ultrasound showed a lower incidence of adverse effects, suggesting that it may be a more suitable option for patients seeking safety and minimal side effects.