Skin physiology and safety of microfocused ultrasound with visualization for improving skin laxity

Abstract

Purpose

The efficacy of microfocused ultrasound with visualization (MFU-V; Ultherapy^®) has been demonstrated in clinical studies and daily practice. However, data addressing skin physiology after MFU-V treatment are lacking. This observational evaluation was aimed to assess skin physiology before and after MFU-V treatment using noninvasive biophysical measurements.

Patients and methods

Twenty-two female patients with moderate-to-severe skin sagging at the jawline and submental region on the Merz Aesthetics Scale obtained a single MFU-V treatment according to protocol. Skin function measurements focused on short-term effects up to 3 days and long-term effects up to 24 weeks after treatment. Skin temperature, transepidermal water loss, skin hydration, erythema, elasticity, and skin thickness and density were evaluated under standardized conditions. Pain was assessed using a validated numeric visual analog scale.

Results

Skin temperature remained in a physiologic range and no significant increase was noted at day 3 after MFU-V treatment. Transepidermal water loss, hydration, and erythema values were fairly stable and showed no significant differences at short- and long-term measurements vs baseline. At week 4 after a single MFU-V treatment, gross and net elasticity values were significantly decreased (P=0.003 and P=0.0001, respectively), followed by significantly increased values at week 12 (P=0.015, P=0.046) and week 24 (P=0.001, P=0.049). Edema due to MFU-V treatment resolved without sequelae. For all patients, pain diminished shortly after treatment. No adverse events occurred during the 24-week follow-up period.

Conclusions

MFU-V treatment is well tolerated and it does not alter the epidermal barrier function or physiology of skin. Significant increase in the elasticity of skin was observed at 12 and 24 weeks after a single treatment, which reflects improvement in dermal tissue function. These short- and long-term effects are congruous with the mode of action of MFU-V due to a proven intrinsic tissue remodeling process.

Keywords:

• skin lifting
• tightening
• neocollagenesis
• epidermal barrier
• elasticity
• energy-based device

Author contributions

MK conducted the evaluation performing visits and instrumental evaluations. ATN and CEN participated in data analyses. SH, JLB, and MK participated in writing, critically revising review, and approving the manuscript. All authors contributed toward data analysis, drafting and revising the paper, gave approval of the final version to be published and agree to be accountable for all aspects of the work.

Disclosure

MK has received research support and has conducted clinical trials for Merz Pharmaceuticals GmbH and has acted as a speaker and/or investigator for Merz, Kythera, Q-Med/Gal-derma, and Pierre Fabre. SH and JLB are employees of Merz Pharmaceuticals. ATN and CEN are scientific employees at the University of Hamburg. The authors report no other conflicts of interest in this work.