Clinical Trial Evaluating the Long-Term Efficacy of Microfocused Ultrasound With Visualization for Décolleté Rejuvenation

November 2020 | Volume 19 | Issue 11 | Original Article | 1026 | Copyright © November 2020


Published online October 30, 2020

doi:10.36849/JDD.2020.5265

Sabrina G. Fabi MD, Monica Boen MD, Marwan Alhaddad MD, Mitchel P. Goldman MD

Cosmetic Laser Dermatology, Goldman, Fitzpatrick, Butterwick, Groff, Fabi, Wu & Boen, San Diego, CA

Abstract
Previous studies have demonstrated the beneficial effects of microfocused ultrasound with visualization (MFU-V) for treating chest wrinkles; however, those studies followed subjects for only 180 days. The objective of the following study was to assess the long-term effects of MFU-V for the treating chest wrinkles. Each subject was treated with 4-4.5 mm, 7-3.0 mm, and 10-1.5 mm transducers. Subjects were subsequently evaluated on post-treatment days 6, 12, 180, and 360. Digital images were obtained of the décolleté area of each subject prior to treatment and at each follow-up evaluation. Wrinkle severity was assessed using the validated Merz Décolletage Wrinkle Scales at each follow-up visit and Subject Satisfaction Questionnaires were completed on post-treatment days 180 and 360. Enrolled subjects (N=20) were female with a mean (SD) age of 54.9 (7.5) years (range, 44 to 71 years). The study was completed by 15 subjects. Subjects achieved a significant decrease in dynamic wrinkle scores over time (P<0.01). Baseline scores were significantly decreased at day 90 (P≤0.01) which remained significant at days 180 and 360 (for each, P<0.01). Subjects also showed significantly decreased at-rest wrinkle scores over time (P≤0.01). Baseline scores were significantly decreased at day 90 (P≤0.01), which remained significant at days 180 and 360 (for each, P=0.01). Mean (SD) subject satisfaction scores increased from 2.9 (1.8) on day 180 to 3.9 (1.8) on day 360.

J Drugs Dermatol. 2020;19(11):1026-1029. doi:10.36849/JDD.2020.5265

INTRODUCTION

Numerous treatments have been developed to treat skin laxity and photoaged skin, including energy-based technologies. The underlying basis for most of these energy-based therapies is to cause immediate collagen coagulation and contraction and stimulate fibroblast activity resulting in long-term neocollagenesis and neoelastogenesis.1,2

A device using microfocused ultrasound (MFU) creates multiple microthermal subcutaneous zones of coagulation of approximately 1 mm3 at specific tissue depths while bypassing the epidermis, resulting in immediate collagen contraction and long-term neocollagenesis and tissue remodeling (Ulthera® System, Merz North America, Inc., Raleigh, NC). This device is designed to be used with an ultrasound imaging transducer (MFU-V) that enables visualization of tissue up to 8 mm below the surface of the skin (DeepSEE® Technology. Merz North America, Inc., Raleigh, NC). Tissue imaging enables the user to avoid non-target tissues such as bone and blood vessels. This non-invasive device is FDA-cleared to lift the eyebrow, improve lax submental and neck tissue, and lines and wrinkles on the décolletage.3 Treatment with MFU-V is well-tolerated and provides improvements in skin laxity without altering epidermal barrier function.4

An initial pilot study assessed the use of MFU-V for treating skin laxity and rhytides on photodamaged areas on the décolletage.5 Enrolled subjects demonstrated significant improvement in wrinkles and skin laxity at post-treatment days 90 and 180. Subject satisfaction was 100% at day 180. Based on these positive results, a larger prospective study further assessed the safety and effectiveness of MFU-V for improving lines and wrinkles of the décolleté.6 A single MFU-V treatment provided significant aesthetic improvement for moderate-to-severe décolleté wrinkles for the 180-day duration of the study and possibly longer. Treating this area with MFU-V creates a smooth transition between the rejuvenated face, neck and chest.

Although the beneficial effects of MFU-V for treating the décolleté have been shown in numerous studies clinically, most were of only 6 month duration.4-6 Only one MFU-V study demonstrated substantial lifting and tightening of facial and neck tissue with a high degree of patient satisfaction for up to 1 year.7 The objective of this following study was to assess the long-term effects of MFU-V for the treatment of the décolleté, as patients commonly ask how long results from a single treatment will last.