GRAPEVINE, TEX. A new ultrasound device was safe and effective for raising the brow line, smoothing facial wrinkles, and adding definition to the jowl line in a study with 33 evaluable patients.
"Ultrasound appears to be a safe, new modality for brow movement. The procedure appears to be extremely safe, and we expect to improve efficacy as the treatment is further refined," Dr. Murad Alam said at the annual meeting of the American Society for Laser Medicine and Surgery.
"This is a fascinating new technology with no side effects and no down time. The results were very impressive, with a dramatic improvement in elevation of the brow," commented Dr. Jeffrey S. Dover, a dermatologist in private practice in Chestnut Hill, Mass.
The device emits an ultrasound beam that was focused 4.5 mm below the skin surface. The goal is to produce thermal coagulation that tightens subepidermal tissue while leaving surface skin unchanged. The investigational device is made by Ulthera Inc. The company is in the process of collecting clinical data to submit to the Food and Drug Administration for device approval, said a company spokesman.
The study involved 35 people, aged 4065 years, and mostly women, with mild-moderate facial laxity. After baseline photography and application of a topical anesthetic, treatment was done as a single pass, in linear arrays up to 25-mm long at 5-mm intervals over the entire face and neck. The ultrasound beam was set at 7.5 MHz at a power of 1530 W, with exposure durations of 1080 milliseconds on the temple, preauricular area, submental area, and neck. An ultrasound beam of 4.4 MHz at 3040 W was applied for 1080 milliseconds on the cheeks using a second type of probe. The total energy from each pulse delivered 0.41.2 J.
Ninety-day follow-up was available for 33 of the 35 treated patients. Clinically significant elevation of the eyebrow line occurred in 90%, with their brow line rising by 1.52.0 mm with an average rise of 1.7 mm. The result was that the eyes opened and the eyebrows appeared raised, said Dr. Alam, chief of cutaneous and aesthetic surgery at Northwestern University in Chicago.
Other common clinical effects were a reduction in forehead static lines, and in periorbital static lines (crow's feet). Also, the jowl line of most patients became better defined, and their neck lines became more recessed. These subjective assessments were made by blinded graders.
The pain of the procedure was graded as 28 (on a 10-point scale). The higher pain scores were rare and were given mostly by patients who had no prior history of a cosmetic procedure.
In no case did the pain lead to stopping treatment. About two-thirds of treated patients developed a mild-moderate erythema and edema that resolved within 1 day of treatment. No patients developed scars, erosions, infections, or muscle or neuron injury.
The study by Dr. Alam was funded by a grant by Ulthera to Northwestern University; Dr. Alam had no individual disclosures in his relationship with the company.
Clinically significant elevation of the eyebrow occurred in 90%, rising an average of 1.7 mm. DR. ALAM