Evaluation of the Ulthera System for Lower Face Rejuvenation
Goals/Purpose:
The goal of anti-aging therapies is a more youthful, rejuvenated face, addressing the lower half of the face, which bears the brunt of gravitational forces, can result in an improved outcome. Currently chemical peels, fillers/botox and laser therapies (ablative and non ablative) are the main non surgical options available to patients for facial rejuvenation, but these have variable clinical outcomes and side effect profiles.
Micro-focused ultrasound (MFU) therapy has been used for various medical indications such as treatment of solid malignant and benign tumors. This has lead to an interest in ultrasound-based treatments for deep tissue skin rejuvenation as it can provide focal thermal necrosis of the dermal tissue initiating the inflammatory cascade leading to tissue remodeling. The Ulthera device utilizes this technology and is designed and configured to produce small (approximately 1 mm3) micro-thermal lesions in the mid to deep reticular layer of dermis and sub-dermis, while sparing overlying papillary dermal and epidermal layers of skin. The device also incorporates an ultrasound imaging capability to evaluate the skin tissue.
The goal of this study was to investigate the clinical response of Ulthera¨ ultrasound treatment system in tightening and lift of the cheek tissue, improvement in jawline definition and submental skin laxity.
Methods/Technique:
Seventy patients were enrolled in this study with masked evaluation. Ultrasound gel was applied and the transducer placed on the targeted skin surface and an ultrasound image is obtained. Each area of the proposed treatment was imaged first with the ultrasound device to ensure coupling between the transducer and skin. During the treatment procedure multiple exposure lines close to each other (2 – 4 mm) were placed by the investigator in the selected area, with each line exposure requiring about 5 seconds. The treatment line was up to a maximum 25 mm long line. Each region of the face and neck was treated in a linear pattern, with a total of 310 lines (see figure 1).
Patients were asked to fill in a questionnaire to assess pain during the procedure and satisfaction with clinical outcome. Blinded and non-blinded objective assessments of pre and post (day 60 and day 90) treatment were made by experienced clinical assessors. The masked and unmasked reviewers had three possible responses: improved, no change, or worsened. Any adverse events were also noted.
Results/Complications:
67% of the patients felt they had skin improvement, with moderate pain response occurring only during the treatment procedure.
Agreement between masked and unmasked reviewers was 74%. The three masked clinicians noted improvement in the lower two-thirds of the face and neck in 62.9% of the subjects.
For all 70 study subjects, there was no damage to the skin epidermis, no case of acute skin damage or long-term sequelae reported during the course of the study.
Conclusion:
Non-surgical rejuvenation of the lower face and neck, particularly improvement in characteristics of skin tightening and laxity can be challenging. The Ulthera device utilizes focused ultrasound based thermal tissue damage to stimulate collagen neosynthesis and therefore skin tightening. This study has demonstrated promising results in lower face rejuvenation with a minimal side effect profile, despite using a lower density treatment (310 lines) than currently recommended (406 lines). Further studies need to be performed to demonstrate its efficacy for a broader range of clinical indications and additionally, a follow-on study is underway to evaluate the efficacy using higher density treatment guidelines.
Figure 1:
