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Safety of microfocused ultrasound with visualization in darker skin types

( Microfocused ultrasound (MFU) treatment to tighten and lift skin on the face and neck appeared to be safe for patients with darker skin types in a small study that resulted in only a few temporary adverse effects, according to a report published online by JAMA Facial Plastic Surgery.

Normal aging results in changes in the skin and underlying connective tissue. A system that uses MFU together with ultrasound visualization was developed to treat lax, aging skin. Previous clinical trials have shown the system to be a safe and effective noninvasive aesthetic treatment, according to the study background.

Monte O. Harris, M.D., of the Center for Aesthetic Modernism, Chevy Chase, Md., and Hema A. Sundaram, M.D., of Dermatology, Cosmetic & Laser Surgery in Rockville, Md., and Fairfax, Va., performed a nonrandomized trial in 52 patients to demonstrate the safety of MFU for improving laxity of the skin in adults with darker skin types (Fitzpatrick skin types III to VI). Of the 52 patients, 35 (67 percent) were black and all but one were women.

The authors report the treatment resulted in three adverse events, which all resolved after 90 days without complications. The events were mild edema (swelling) or welts and moderately severe prolonged erythema (reddening of the skin) with mild scabbing and were associated with treatment technique, according to the results.

"When performed by trained physicians, MFU is safe in patients with Fitzpatrick skin types III to VI," the study concludes. (JAMA Facial Plast Surg. Published online August 27, 2015. doi:10.1001/jamafacial.2015.09990. Available pre-embargo to the media at

Editor's Note: This study was sponsored by Ulthera, Inc. Please see the articles for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Commentary: Options, Challenges for Facial Rejuvenation in Patients with Higher Fitzpatrick Skin Phototypes

In a related commentary, Oneida Arosarena, M.D., of Temple University, Philadelphia, writes: "The proven safety of microfocused ultrasound in patients with Fitzpatrick skin types III to VI adds another instrument to the armamentarium of nonablative facial rejuvenation for surgeons who treat patients with all skin types. Further studies are needed to determine the efficacy of this therapy in patients of color." (JAMA Facial Plast Surg. Published online August 27, 2015. doi:10.1001/jamafacial.2015.0965. Available pre-embargo to the media at

Editor's Note: Please see the articles for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.


Media Advisory: To contact corresponding author Monte O. Harris, M.D., call 301-951-9292 or email To contact commentary author Oneida Arosarena, M.D., call Jennifer Lee at 215-707-7424 or email or call Jeremy Walter at 215-707-7882 or email An author audio interview will be available when the embargo lifts on the JAMA Facial Plastic Surgery website:


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