SAN FRANCISCO (FRONTLINE MEDICAL NEWS)– Micro-focused ultrasound therapy led to measurable improvements in erythematotelangiectatic (type 1) rosacea, and patients reported no serious adverse effects, according to interim results from a small, multicenter, single-blinded randomized study.

Thus far, two high-density treatments with the ultrasound device seem to give the best outcomes, Dr. Joel Schlessinger reported at the annual meeting of the American Academy of Dermatology.

“A lot of patients were dramatically improved later on in the trial, so when we publish the final data, I think it will be even more impressive than what we were able to report today,” added Dr. Schlessinger, a dermatologist practicing in Omaha, Nebraska.

Rosacea affects an estimated 16 million patients in the United States, and the erythematotelangiectatic (type 1) subtype is most common. Despite its prevalence, treatment options are limited and its pathophysiology is not fully understood. The interim results reported at the AAD meeting are for 38 adults aged 21 to 61 years who underwent treatment with the Ulthera® device for erythematotelangiectatic (subtype 1) rosacea. Patients had baseline Clinician Erythema Assessment (CEA) scores of at least 3, and 83% had moderate disease based on the patient self-assessment of erythema, while 8% had mild disease and 17% had severe disease, Dr. Schlessinger said.

Patients were randomized to four treatment arms consisting of either one or two low or high-density treatments. The low-density treatment consisted of 15 ultrasound lines per standardized facial treatment square, while the high-density treatment used 30 lines per square. Investigators treated patients’ cheeks and chins with a 4MHz 4.5 mm transducer, infraorbital areas and noses with a 7MHz 3.0mm transducer, and foreheads with a 10MHz 1.5mm transducer.

The interim analysis included 38 patients who averaged 50 years of age and 87% of whom were female. At day 90, two-thirds of patients had improved by at least one grade on the CEA, including 60% of the low-density treatment groups, all of the high-density, single-treatment group, and one-third of the high-density, multiple-treatment group. Patient self-assessment scores at day 180 were only available for seven patients, but four reported improvements of at least one grade, including three of four patients in the high-density treatment groups, Dr. Schlessinger said.

About 55% of patients experienced mild bruising and raised erythemic regions at the treatment sites, which typically lasted 10 days. Other common adverse events included self-reported soreness (affecting 44% of patients), and flat erythemic areas (26%). Almost one in five patients reported paresthesia, which lasted an average of 12 days.

Patients reported similar average pain scores (ranging from 4.1 to 6.4 on a 10-point scale) regardless of treatment density, Dr. Schlessinger noted. “Pain scores were what really surprised me, and in a good way,” he added. “All people had [for analgesia] was Tylenol or Advil.”

The study aims to enroll 88 patients. Thus far, two high-density dual therapy treatments seem to be more effective compared with one treatment for superficial treatments. Exactly how micro-focused ultrasound improves rosacea remains unclear. “Perhaps the higher the energy level, the more chance it will cause damage that will potentially translate to the rosacea mechanism of flushing or blood vessel activation,” he said. “Ulthera is such an unusual device and I was initially dubious about it, but it seems to be a very useful tool,” Dr. Schlessinger said.

The protocol was modified during the study to create the multiple treatment subgroups. The trial also excluded a number of patients, including those with three or more rosaceatic papules or pustules; more than five prominent telangiectases in the treatment area (except on the sides of the nose); intense flushing in response to a few triggers (such as postmenopausal hot flashes or certain foods); papulopustular, phymatous, or ocular rosacea; rosacea conglobata; rosacea fulminans; isolated rhinophyma; isolated pustulosis of the chin; and skin conditions that resembled rosacea, such as peri-oral dermatitis and facial keratosis pilaris.

Dr. Schlessinger has relationships with numerous pharmaceutical and device companies, including Ulthera, Inc., which makes the device tested in the trial.

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