Evaluation of a microfocused ultrasound system for improving skin laxity and tightening in the lower face

Georgette Oni; Ron Hoxworth; Sumeet Teotia; Spencer Brown; Jeffrey M Kenkel

doi:10.1177/1090820X14541956

Evaluation of a microfocused ultrasound system for improving skin laxity and tightening in the lower face

Aesthet Surg J. 2014 Sep;34(7):1099-110. doi: 10.1177/1090820X14541956. Epub 2014 Jul 2.

Authors

Georgette Oni¹, Ron Hoxworth¹, Sumeet Teotia¹, Spencer Brown¹, Jeffrey M Kenkel²

Affiliations

¹ Dr Oni is a research fellow, Drs Hoxworth and Teotia are assistant professors, and Dr Kenkel is a professor and vice-chairman of the Department of Plastic Surgery, University of Texas Southwestern Medical Center, DallasDr Brown is a professor and executive director of the Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.
² Dr Oni is a research fellow, Drs Hoxworth and Teotia are assistant professors, and Dr Kenkel is a professor and vice-chairman of the Department of Plastic Surgery, University of Texas Southwestern Medical Center, DallasDr Brown is a professor and executive director of the Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania jeffrey.kenkel@utsouthwestern.edu.

PMID: 24990884
DOI: 10.1177/1090820X14541956

Abstract

Background: The Ulthera System (Ulthera, Inc, Mesa, Arizona) employs microfocused ultrasound to cause discrete focal heating of the dermis and stimulate neocollagenesis and elastin remodeling.

Objectives: The authors investigated tightening and lifting of cheek tissue, improvement in jawline definition, and reduction in submental skin laxity in patients treated with the Ulthera System.

Methods: A total of 103 adults were enrolled in this prospective nonrandomized clinical trial. Three-dimensional photographs obtained at baseline and 3 months posttreatment were assessed qualitatively by 3 blinded reviewers and quantitatively with AutoCAD software (Informer Technologies, Redwood City, California). The relationship between outcomes and body mass index (BMI) was examined as well. Patients rated pain during the procedure and provided subjective assessment of their outcome at 90 days. Adverse events were documented.

Results: Ninety-three patients were evaluated. Blinded reviewers observed improvement in skin laxity in 58.1% of patients. During quantitative assessments, overall improvement in skin laxity was noted in 63.6% of evaluated patients. No change was detected in 54.5% of patients whose BMI exceeded 30 kg/m2 or in 12.2% of patients whose BMI was ≤30 kg/m2. At day 90, 65.6% of patients perceived improvement in the skin laxity of the lower half of their face/neck. The average procedural pain scores for the cheek, submental, and submandibular regions were 5.68, 6.09, and 6.53, respectively. Wheals, which resolved without intervention or long-term sequelae, were reported for 3 patients.

Conclusions: To the authors' knowledge, this is the largest clinical study of the effectiveness of the Ulthera System for rejuvenation of the lower face. At day 90, improvements were reported by two-thirds of patients and by nearly 60% of blinded reviewers. Outcomes were better in patients with BMI≤30 kg/m2.

Level of evidence: 2.

Keywords: Ulthera; facial rejuvenation; microfocused ultrasound; nonsurgical skin rejuvenation.

Publication types

Clinical Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Age Factors
Body Mass Index
Cosmetic Techniques / adverse effects
Cosmetic Techniques / instrumentation*
Equipment Design
Face*
Female
Humans
Male
Middle Aged
Pain / etiology
Patient Satisfaction
Prospective Studies
Rejuvenation*
Skin Aging*
Texas
Time Factors
Treatment Outcome
Ultrasonic Therapy / adverse effects
Ultrasonic Therapy / instrumentation*