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

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.