A study in intense focused ultrasound, microfocus ultrasound versus macrofocus ultrasound and the effect of static line at crows feet,infraorbital laxity, infraorbital rhytids: A prospective, randomized, double-blinded, intraindividual split face study
Abstract:
With the growing demand for non-surgical skin tightening treatments, various technologies have been developed to address skin laxity. One such technology that has proven to be both safe and effective in treating infraorbital laxity and infraorbital rhytids (under-eye wrinkles) is high-intensity focused ultrasound (HIFU). A well-known prototype device for treating periorbital wrinkles, such as the Ulthera system, remains limited by its high treatment cost. Additionally, it delivers ultrasound energy in an oval-shaped pattern, requiring higher intensity to penetrate deeper skin layers. This generates significant heat and can cause discomfort, rendering the treatment intolerable for some patients.
Another challenge in this field is the treatment of static lines (deep wrinkles), which are often addressed with fractional laser treatments such as Fraxel, or with fractional microneedle radiofrequency devices like eMatrix or Venus Viva. However, these methods are associated with longer recovery times and common adverse effects, such as post-inflammatory hyperpigmentation. Given these concerns, the researcher posed the question of whether another brand of HIFUUltraformer IIIcould serve as a viable alternative. This system has lower treatment costs and incorporates an innovative round-shaped transducer tip, along with MMFU (Micro and Macro Focused Ultrasound) technology, which allows for the delivery of broader energy pulses. These pulses induce subdermal heating with minimal downtime, potentially making the treatment more accessible to a broader patient population. To date, no prior study has directly compared the efficacy of these technologies in treating periorbital wrinkles.
Thus, this study aimed to compare the effectiveness of the Ultraformer III device using two different handpieces: the 1.5 mm microfocused ultrasound and the 2.0 mm macrofocused ultrasound. The objective was to evaluate which modality was more effective in treating crows feet wrinkles, infraorbital laxity, and under-eye wrinkles.
This prospective, randomized, evaluator- and subject-blinded, split-face study included 12 participants aged between 35 and 60 years, all presenting with varying degrees of under-eye wrinkles, infraorbital laxity, and crows feet. Each subject received treatment on one side of the face using the 1.5 mm microfocused ultrasound and on the opposite side using the 2.0 mm macrofocused ultrasound. Follow-up assessments were conducted at weeks 1, 6, and 12 post-treatment. Efficacy was evaluated using the Visioscan® device, which measured several skin parameters: skin roughness (SEr) and skin smoothness (SEsm) for crows feet wrinkles, and skin wrinkle values (SEw) for under-eye wrinkles.
The results demonstrated that both devicesmicrofocused ultrasound (1.5 mm) and macrofocused ultrasound (2.0 mm)were similarly effective in improving infraorbital laxity and under-eye wrinkles. At both week 6 and week 12, there were statistically significant improvements in average skin elasticity and reductions in wrinkle scores as assessed by photographic analysis (with wrinkle reduction ranging from 1% to 25%).
Regarding patient satisfaction and pain levels during treatment, no significant differences were observed between the two devices. As for adverse effects, mild and transient erythema was reported in 2 out of 12 participants (16.7%) who received treatment with the 1.5 mm microfocused ultrasound, compared to 4 out of 12 participants (33.3%) in the 2.0 mm macrofocused ultrasound group. The incidence of side effects was significantly lower in the microfocused ultrasound group.