Sponsored By Sofwave;
Results from a multi-center clinical study suggest that the Sofwave™ device from Sofwave (San Clemente, Calif.), may offer physicians the versatility needed to improve the appearance of acne scars in patients from a variety of demographics. Having recently gained clearance by the U.S. Food and Drug Administration (FDA) to treat acne scars, this high-intensity ultrasound device is also cleared to improve facial lines and wrinkles, lift the eyebrows, lift lax submental and neck tissue, and treat cellulite short term.
Researchers at four sites across the U.S. used Sofwave’s synchronous ultrasound parallel beam (SUPERB™) technology to treat moderateto-severe acne scars in 67 subjects with a variety of skin types, ranging in age from 18 to 80 years old. This device delivers high-intensity ultrasound to the mid-dermis at a depth of about 0.5 mm to 2.0 mm, increasing skin tissue temperatures to 60° C to 70° C with simultaneous feedback-controlled skin cooling. Treatment results in the production of collagen and elastin.
“An acne scar is like a deep crater in the skin. We want to build up the damaged skin tissue to help fill in that crater,” explained David Goldberg, MD, JD, dermatologist and medical director of Skin Laser & Surgery Specialists, a division of Schweiger Dermatology Group (New York City, N.Y.), who was involved in the study. “Sofwave does this by creating new collagen below the skin as well as tightening the skin, which makes the scar less obvious.”
Participants received three treatments every two to four weeks, which targeted about 1.5 mm below the area of the skin affected by acne scars. Results were measured at one month and three months post-treatment. At three months, masked evaluators noted that 97% of subjects showed an average improvement of 46% relative to the average baseline acne scars severity grading, while 88% of subjects reported improvement in their acne scar appearance. There were no adverse events reported.
“By including patients with many different skin types across a wide range of ages, we were able to really see the distinct benefits this device can offer patients based on their individual skin needs,” said Anne Chapas, MD, dermatologist and medical director of UnionDerm (New York City, N.Y.), who was also involved in the study. “In younger patients, we saw improved texture of scars while, in older patients, we saw the device address skin sagging caused by both post-acne inflammation and aging.”
“What really impressed me was how well patients with darker skin did with the treatment,” Dr. Goldberg shared. “It can be very challenging to treat darker skin types with many of these energy-based technologies due to the risk of hyperpigmentation after treatment, but we had no issues. This treatment is beyond safe for patients with skin of color.”
Dr. Chapas also mentioned the absence of downtime for acne scar patients. “Almost every other device-based treatment for acne scars has some recovery time,” noted Dr. Chapas. “But with this, there was absolutely nothing.
“This device ultimately gives us some versatility,” she added. “We can treat both younger and older patients with any skin type non-invasively, and we have the data to back it up.”
References:
1. https://www.biospace.com/article/releases/sofwavemedical-announces-fda-clearance-of-superb-technology-fortreatment-of-acne-scars/
2. O’Daniel TG. Multimodal management of atrophic acne scarring in the aging face. Aesthetic Plast Surg. 2011 Dec;35(6):1143-50. doi: 10.1007/s00266-011-9715-y. Epub 2011 Apr 14. PMID: 21491169; PMCID: PMC3236289.
3. Teymour, S, Kania, B, Lal, K, Goldberg, D. Energy-based devices in the treatment of acne scars in skin of color. J Cosmet Dermatol. 2023; 22: 1177-1184. doi:10.1111/jocd.15572
