Soliton Inc announces positive 12-week follow-up results from a proof-of-concept (POC) study using its Rapid Acoustic Pulse (RAP) Device for the treatment of fibrotic (keloid and hypertrophic) scars.
The data was presented in the abstract, “Volume And Height Reduction of Fibrotic Scars Shown With 3D Imaging 12 Weeks After Non-Invasive Treatment With a Rapid Acoustic Pulse (RAP) Device In a Proof Of Concept Study” at the Maui Derm for Dermatologists 2020 meeting.
“We were excited to share the 12-week follow-up results at this key dermatology conference, amongst some of the top physicians in this field,” says Christopher Capelli, MD, founder, President and CEO of Soliton, in a media release.
“The clinical results clearly demonstrate that an overall average reduction in both the volume of the scars and the height of the scars at the 12-week follow-up after the initial single 6-minute treatment is continuing without the need for further dosing. We are very encouraged by these positive results that further substantiate the merit of our RAP device and look forward to continuing the development and enhancement of its clinical program.”
The objective of this single-site POC IRB-approved human clinical study was to evaluate the safety, tolerability, and efficacy of the RAP device for the temporary improvement in the appearance of fibrotic scars. A single 6-minute RAP session was used to treat 11 fibrotic scars in 10 participants.
Images were analyzed using proprietary software for changes in scar volume and height from pretreatment to the 12 week follow-up. 3D scar assessment of the pre- and post-treatment photographs of 11 treated scars demonstrated an average reduction in volume of 29.6% (p<0.01) and an average reduction in height of 14.6% (p<0.005), the release explains.
While the 12 week data represents an improvement in volume reduction over the 6-week volume reductions of 27% previously announced, this was without any additional treatment, suggesting that the scars continued to improve over time. This continued improvement from a single treatment is especially important as keloid scars are prone to recurrence after treatment with existing therapies.
Patients treated with steroid injections see recurrence rates as high as 50%, while patients treated with a chemotherapeutic agent have recurrence rates as high as 47%.
Overall, the treatment of fibrotic scars using the RAP device proved safe and tolerable during this POC study. Follow-up results at 12 weeks demonstrate that the RAP device provides significant improvements in the appearance of fibrotic scars from a single 6-minute noninvasive treatment, with minimal pain, and most patients express satisfaction with the scar improvement, the release continues.
[Source(s): Soliton Inc, PR Newswire]