Ultrasound tightening of facial and neck skin: A rater-blinded prospective cohort study

Background: Nonablative skin tightening technologies offer the prospect of reduction of wrinkles and skin sagging with minimal downtime, discomfort, and risk of adverse events. The excellent safety profile is mitigated by the limited efficacy of such procedures. Objective: We sought to assess the efficacy of ultrasound skin tightening for brow-lift in the context of a procedure treating the full face and neck. Methods: This was a rater-blinded, prospective cohort study at a dermatology clinic in an urban academic medical center. Subjects were medicated with topical anesthetic and then treated with an investigational focused intense ultrasound tightening device to the forehead, temples, cheeks, submental region, and side of neck using the following probes: 4 MHz, 4.5-mm focal depth; 7 MHz, 4.5-mm focal depth; and 7 MHz, 3.0-mm focal depth. Standardized photographs of front and side views were obtained at 2, 7, 28, 60, and 90 days; rating scales of pain, adverse events, physical findings, and patient satisfaction were also completed. Primary outcome measure was detection of improvement in paired comparison of pretreatment and posttreatment (day 90) photographs by 3 masked expert physician assessors, cosmetic and laser dermatologists, and plastic surgeons who were not authors. Second primary outcome measure was objective brow elevation as quantitated by a standard procedure using fixed landmarks. Secondary outcomes measure was patient satisfaction as measured by a questionnaire. Results: A total of 36 subjects (34 female) were enrolled, one subject dropped out, and 35 subjects were evaluated. Median age was 44 years (range 32-62). On the first primary outcome measure, 30 of 35 subjects (86%) were judged by the 3 masked experienced clinician raters to show clinically significant brow-lift 90 days after treatment (P = .00001). On the second primary outcome measure, mean value of average change in eyebrow height as assessed by measurement of photographs at 90 days was 1.7 mm. Limitations: Limitations of this study include the inability to quantitatively measure lower face tightening because of the lack of fixed anatomic landmarks in this area. Conclusion: Ultrasound appears to be a safe and effective modality for facial skin tightening. A single ultrasound treatment of the forehead produced on average brow height elevation of slightly less than 2 mm. Most treated individuals responded, commonly with accompanying transitory mild erythema and edema.