A microfocused ultrasound (MFU) system is a safe and effective aesthetic treatment for tightening and lifting skin in the facial and neck areas. This open-label, nonrandomized trial was performed to further demonstrate the safety of MFU for improving laxity of the skin of the face and neck in 52 adults with Fitzpatrick skin types III to VI.
Before treatment with MFU, the skin tissue of each participant was assessed and ultrasound imaging was performed on the treatment area to ensure appropriate acoustic transducer coupling. Treatment was performed from March 23, 2011, to July 20, 2011. Following treatment, there were 3 reported adverse events described as raised areas of mild edema or welts (2 events) and moderately severe prolonged erythema with mild scabbing (1 event). All events resolved after 90 days without sequelae. Analysis was conducted from Janaury 18, 2012, to March 13, 2013.
Conclusions and Relevance
The adverse events that occurred in this trial were temporary and associated with treatment technique. When performed by trained physicians, MFU is safe in patients with Fitzpatrick skin types III to VI.
Level of Evidence
clinicaltrials.gov Identifier: NCT01368965
Normal aging results in characteristic changes in the skin and underlying connective tissue. These changes, which include facial rhytids and laxity, result from cutaneous photo damage after repeated sun exposure as well as other factors, such as age and genetic predisposition.1 These factors change the 3-dimensional structure of skin collagen, leading to a loss of its inherent elasticity.
A system that uses microfocused ultrasound (MFU) together with ultrasound visualization (MFU-V) was developed to treat lax, aging skin by producing a series of small, subcutaneous focal zones of thermal microcoagulation. The system delivers ultrasound energy to cutaneous layers in the skin, such as the reticular dermis. The device produces small (approximately 1 mm3) microcoagulation zones in the middle to deep reticular layer of the dermis and subdermis while sparing the overlying papillary dermal and epidermal layers. This focused energy causes collagen to become denatured and contract, with subsequent de novo synthesis and remodeling, which results in lifting and tightening of lax skin.1 Unlike other energy devices, focused ultrasound is a “color-blind” technology as the energy is not selectively absorbed by chromophores. The MFU device is also capable of ultrasound imaging, which can be used to visualize the region of interest and ensure acoustic coupling before applying MFU. This system (Ulthera System; Ulthera, Inc) is indicated for noninvasive dermatologic aesthetic treatment to lift the eyebrow and lax submental, neck, and décolleté tissue.2
Available transducers are capable of emitting ultrasound energy over a range of frequencies (4 MHz [high energy], 7 MHz [intermediate energy], and 10 MHz [low energy]) and treatment depths (1.5, 3.0, or 4.5 mm). All transducers are capable of imaging tissue to a depth of 8 mm. Using appropriate transducers, the target area is treated in a lined pattern of microcoagulation zones spaced 2 to 3 mm apart.
Previous clinical trials have demonstrated the MFU-V system to be a safe and effective noninvasive aesthetic treatment for tightening and lifting skin in the facial and neck areas. When properly used, MFU-V has been shown to have an excellent safety profile.
An open-label, nonrandomized trial was performed from March 23, 2011, to July 20, 2011, to assess the safety of MFU-V for improving skin laxity of the face and neck in 52 adults with Fitzpatrick skin types III to VI (Table). Analysis was conducted from January 18, 2012, to March 13, 2013. The full study protocol, which can be found in the trial protocol in the Supplement, was approved by the Asentral, Inc, institutional review board. Participants provided written informed consent before participating in any study-related procedures.
The MFU-V treatment was performed according to the physical characteristics of each participant. Before initiating treatment, the skin tissue was assessed based on age, sex, and the amount of subcutaneous soft tissue in the area to be treated. Ultrasound imaging was performed on the treatment area to ensure appropriate acoustic coupling of the transducer to the skin surface before treatment. The lower face and submental regions were treated with 4.4- and 7-MHz transducers with focal depths of 4.5 and 3.0 mm, respectively. Each participant was treated with approximately 370 lines of MFU-V with a maximum length of 25 mm and microcoagulation zones spaced 2 to 3 mm apart. Participants returned at 90 and 180 days for follow-up to assess safety and effectiveness, which included photography to evaluate clinical improvement of face and neck, assessment for adverse events, Global Aesthetic Improvement Scale score, and Patient Satisfaction Questionnaire. Individuals who experienced adverse events were contacted periodically by telephone.
Among the 52 participants, mean age was 53 years (range, 32-64 years), 35 (67%) were African American/black, and all but 1 were women (Table). Following treatment, each participant was examined for evidence of acute responses, such as erythema or edema, approximately 30 minutes after exposure. Three self-limiting adverse events were reported that were determined to be unrelated or unlikely to be related to the MFU-V device but likely related to the procedure or technique. One was described as prolonged erythema with mild scabbing and determined to be of moderate severity. The other 2 events were considered mild and consisted of raised areas of mild edema or welts (Figure). All 3 adverse events were considered to be owing to localized, suboptimal coupling and/or contact with the skin during treatment. All 3 events resolved after 90 days without sequelae. For the remaining 49 participants, the skin surface remained intact and there was no damage to the epidermis. No cases of acute skin damage or long-term sequelae, such as scarring, burns, hypopigmentation, hyperpigmentation, or ulceration, were reported during the study. There were no neurologic adverse events.
Raised areas of mild edema or welts, considered to be owing to localized, suboptimal coupling and contact with the skin. The event resolved spontaneously within 90 days without sequelae.
Microfocused ultrasound with visualization has an excellent safety profile.3 Numerous peer-reviewed publications have demonstrated that the system is safe and effective for tightening skin laxity on the face and neck4- 8 and noninvasive for lifting skin on the arms, thighs, and knees.9,10 When used on facial areas, most reported adverse events with MFU-V have consisted of mild erythema,4- 7,11- 14 edema,4- 7,11- 14 bruising and tenderness,4 and dysesthesia or numbness.6,11,14 Uncommon events included elevated wheals or white linear striations of the neck that resolved with no sequelae5,6,11,13,15; in 2 reports,5,6 these events were attributed to improper transducer coupling. There was also a single report of purpura that resolved without sequelae.7
This study was specifically designed to assess the safety and effectiveness of MFU-V in individuals with Fitzpatrick skin types III to VI. Three patients experienced temporary erythema and welting, while the remaining 49 patients experienced no adverse effects. Before treatment, the target area should be visualized with imaging ultrasound to ensure proper coupling and to verify that there is not too much gel on the skin. The adverse events occurred following the use of the more superficial 7-MHz, 3.0-mm transducer. As a precaution, extra care is warranted when using superficial transducers owing to the more reactive nature of superficial skin. Although postinflammatory hyperpigmentation is a potential risk when treating patients with pigmented skin, no hyperpigmentation occurred in any of the participants in this trial.
The safety of aesthetic procedures in individuals with darker skin types is a significant concern for patients and physicians alike. This trial demonstrated a favorable safety profile for MFU-V in individuals with Fitzpatrick skin types III to VI.
Accepted for Publication: June 3, 2015.
Corresponding Author: Monte O. Harris, MD, Center for Aesthetic Modernism, 5530 Wisconsin Ave, Ste 612, Chevy Chase, MD 20815 (email@example.com).
Published Online: August 27, 2015. doi:10.1001/jamafacial.2015.0990.
Author Contributions: Drs Harris and Sundaram had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Both authors.
Acquisition, analysis, or interpretation of data: Both authors.
Drafting of the manuscript: Both authors.
Critical revision of the manuscript for important intellectual content: Both authors.
Obtained funding: Sundaram.
Administrative, technical, or material support: Both authors.
Study supervision: Sundaram.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was sponsored by Ulthera, Inc.
Role of the Funder/Sponsor: The sponsor was involved in the study design; management, analysis, and interpretation of the data; preparation, review, approval, and decision to submit the manuscript. The sponsor was not involved in the conduct of the study or data collection.
Additional Contributions: Carl Hornfeldt, PhD, Apothekon, Inc, provided editorial assistance during the preparation of this article. He was compensated by Ulthera, Inc, for his contribution.
Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. JAMA Facial Plast Surg. 2015;17(5):355-357. doi:10.1001/jamafacial.2015.0990