Device That Combines US, RF Promising for Wrinkles, Skin Laxity

SAN DIEGO – Combining radiofrequency and targeted ultrasound demonstrated significantly better improvements in the quality of wrinkles and skin laxity in the facial region compared with radiofrequency alone at 3 months, results from a multicenter blinded trial showed.

"We've done a lot of work with radiofrequency, and we've done a lot of work with ultrasound," Suneel Chilukuri, MD, said in an interview in advance of a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. "The question becomes, is there truly a difference if we're combining them together?"

To find out, Chilukuri, a dermatologist who practices in Houston, Tex., and colleagues conducted an IRB-approved trial of a new device that allows for the delivery of radiofrequency (RF) and targeted ultrasound (TUS) in a single applicator. The device, which is not yet named, has been cleared by the Food and Drug Administration and is expected to be available in the fourth quarter of 2022.

In a single‐blinded study, 21 adults were randomized to receive RF and TUS (group A), while 20 received RF alone (group B). The mean age of patients was 57 years and 38 were women. Patients in each group received four full‐face treatments delivered once per week. Chilukuri and colleagues used the ElastiMeter to quantitatively measure skin properties at baseline, 1‐month, and 3‐month follow‐up visits. They also took digital photos at each follow-up visit and applied the Fitzpatrick Wrinkle and Elastosis Scale (FWS), and the Global Aesthetic Improvement Scale (GAIS scale) to each one, in addition to performing 3D analysis.

Chilukuri reported that patients in group A showed superior improvement of skin elasticity compared with those in group B. At 3 months, the preliminary skin elasticity data showed an improvement in the periorbital region by 13.6 N/m (34.7% improvement) and 8.1 N/m (22.2% improvement) in group A and B, respectively. (N/m is a measure of elasticity.)

3D photographs also demonstrated superior results in group A, achieving an improvement of 5.3 points (27.7%) and 4.6 points (24.4%) in wrinkles and skin evenness, respectively. Those in group A achieved marked improvement in both FWS and GAIS scales, compared with their counterparts in group B, he said.

"I think this is going to be one more very useful, versatile tool in our toolbox," Chilukuri said of the new device, noting that for both the investigators and the patients, there was greater treatment satisfaction for the areas treated with combined radiofrequency and ultrasound. "It's something that's effective, painless, and the treatment time is very short – approximately 10 minutes per side. It's extremely tolerable and the results were similar to 6-month results I get with fractionated ablative resurfacing, but without the downtime, without the handholding, without any pain."

Moreover, he added, many patients in the trial have asked to have further treatments "and are on a waiting list for when the product launches."

He and his colleagues also observed improvements in skin hydration among patients in group A, based on readings from a MoistureMeterSC, which measures skin hydration, a finding that he characterized as "unexpected and interesting."

Chilukuri speculated that combining TUS and RF allows for better heat dispersion into the epidermis. "If you get to the proper temperature, which is somewhere between 40 and 42 degrees, and if you can keep it for about 10 minutes, we know that there will be proper stimulation of senescent fibroblasts," he explained.

"I can't say that seborrheic keratosis is improved or hyperpigmentation is improved, but the heat generation leads to immediate vasodilation to improve blood flow to treated areas. That results in immediate collagen contraction as well as improved autophagy, removal of age-related cellular debris. With the long term neovascularization, you're going to see more change with the fibroblast activity leading to collagenesis and elastogenesis."

Use of the device is not indicated for patients with metal implants in the head and neck region, he noted. "I'd also be cautious about using it in people with melasma as the device's mechanism is based on heat," since current scientific evidence shows that heat can worsen melasma, he added. "For now, I recommend caution until we perform a split-face study or develop specific treatment parameters for those patients with melasma."

"We know that skin tightening is a difficult task for a nonablative, nonsurgical device," said Murad Alam, MD, professor and vice-chair of dermatology and chief of the section of cutaneous and aesthetic surgery at Northwestern University, Chicago, who was asked to comment on the study.

"The promise is of limited downtime, lack of scars, and minimal discomfort, but we haven't yet had a home run. As a consequence, there's a constant effort to develop new and better devices. This study is interesting because it shows that yes, a new and better device might be good, but let's not overlook the idea of having multiple devices at the same time. The nice thing they've shown is that from a safety standpoint, using both radiofrequency and ultrasound was tolerable in terms of safety, discomfort, and downtime."

BTL Aesthetics, the manufacturer, loaned the device used in the trial. Chilukuri reported having no other financial conflicts for this study. Alam reported having no disclosures.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

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