An ongoing pilot study suggests micro-focused ultrasound with visualization technology, which is FDA cleared for non-invasive lifting around the eyebrows, under the chin and on the décolleté, is a well-tolerated and potentially effective noninvasive option for buttock lifting.
The technology, called the Ulthera System (Ulthera) is not yet cleared for lifting the buttock, according to Sabrina Fabi, M.D., a dermatologist and dermatologic cosmetic surgeon and associate research director at Cosmetic Laser Dermatology, San Diego, Calif. Dr. Fabi presented a prospective, single-site pilot study on the safety and effectiveness of micro-focused ultrasound with visualization for lifting the buttock at yesterday’s American Society for Laser Medicine & Surgery 2015 annual conference in Kissimmee, Fla.
“The Ulthera System has been demonstrated to be safe and effective in previous clinical trials as a non-invasive treatment to produce improvement in the areas of treatment through sub-dermal tissue coagulation and tightening, and for ultrasonic visualization of depths up to 8 mm below the surface of the skin and subdermal tissue,” Dr. Fabi says. “The Ulthera System has been demonstrated to be safe and effective in previous clinical trials as a non-invasive treatment to produce improvement in the areas of treatment through sub-dermal tissue coagulation and tightening, and for ultrasonic visualization of depths up to 8 mm below the surface of the skin and sub-dermal tissue.”
According to the dermatologist, the system includes a transducer, which integrates high-resolution ultrasound imaging with ultrasound therapy. Unfocused ultrasound energy allows clinicians to visualize the treatment area while focused ultrasound energy, or energy delivered at specific treatment depths, induces thermal coagulation. Small micro-coagulation zones cause thermal tissue contraction and results in a healing response and collagen synthesis.
The single-center, randomized, split-body pilot study includes up to 24 treated female subjects with mild to moderate buttock ptosis based on investigator evaluation. Researchers performed two single-side micro-focused ultrasound with visualization treatments 90 days apart at treatment depths of 4.5 mm and 3.0 mm. Pre-treatment, all subjects received IM ketorolac tromethamine, as well as 10 mg diazepam, if needed.
Using the 1-to-10 pain Numeric Rating Scale, subjects reported their average level of treatment-related discomfort. Researchers took pre-treatment and post-treatment 2D/3D photographs and collected quantitative buttock measurements, qualitative Buttock Improvement Scale scores and subject satisfaction at 90, 180 and 270 days post-treatment.
"Interim data is favorable, with approximately 50% of subjects showing improvement or very much improved 3 months later. As with previous studies, we expect full results at 6 months," she says. “Early pilot study interim analyses are showing positive results; however, further investigation is required to confirm safety and effectiveness. The completed treatments to date in the pilot study were well-tolerated.”
References: Dr. Fabi is a consultant for Merz and Ulthera and serves on the speakers’ bureau and has served on the ad boards for Merz and Ulthera.