Patients treated with Soliton’s investigational Rapid Acoustic Pulse (RAP) device experienced an average 32.5 percent improvement in Cellulite Severity Score, according to newly released data presented via the American Academy of Dermatology (AAD) 2020 VMX Virtual Conference.
The pivotal cellulite clinical trial enrolled and treated 67 subjects at four clinical sites, of which 62 subjects were evaluated in the results analysis (five patients were excluded for violation of inclusion criteria or incomplete follow-ups). Eighty-five percent of subjects responded to treatment with the improvement in the Cellulite Severity Scores ranging from 6.7 percent to 85.7 percent.
Elizabeth Tanzi, MD, Director at Capital Laser & Skin Care, Chevy Chase, MD and a member of Soliton’s Scientific Advisory Board, presented the results at the AAD. She noted in an interview with Practical Dermatology magazine that the new technology shows substantial promise.
While existing therapies provide some benefit, “there's a lot of room for improvement,” Dr. Tanzi suggests. “This technology is exciting to me for a number of reasons. First, this was a single treatment. We need additional research to determine what happens after multiple treatments. Also, we need to investigate the best interval between treatments because what we are seeing is that clinical results seem to improve over time, which is the exact opposite from the non-invasive treatments that are on the market today.”
Dr. Tanzi says it is noteworthy that treatment effects were clinically evident, and patient satisfaction with treatment was high. “The three independent evaluating physicians were able to correctly identify before and after photos about 85 percent of the time,” Dr. Tanzi says. “I think that's important, as well as the overall subject satisfaction. When asked if their cellulite appeared improved, 92 percent of the subjects said they agreed or strongly agreed.
Subjects in the study received a single treatment to one buttock and thigh area, with the contralateral side serving as a control. Results were assessed using the validated Simplified Cellulite Severity Scale. Treatment was administered with no pain control. No unexpected or serious adverse events were reported, and the average pain scores were 2.4 on a 10-point scale.