Pulse Biosciences Inc announces positive results from its clinical efficacy study using proprietary Nano-Pulse Stimulation (NPS) technology to treat patients with Sebaceous Hyperplasia (SH), a difficult-to-treat skin condition that typically presents on the face.
Initial data indicate that 221 of 222 (99.5%) facial SH lesions treated with NPS energy were rated as clear or mostly clear by clinical investigators 60 days post treatment.
NPS is a non-thermal technology that utilizes ultra-short, nanosecond energy pulses that directly interacts with the physical structure of cells without disrupting the integrity of non-cellular tissues.
This SH study builds upon previous study results showing the safety and clinically meaningful outcomes of NPS treatment to remove Seborrheic Keratosis lesions. Further, successful elimination of Sebaceous Hyperplasia lesions substantiates the unique ability of NPS to penetrate into the dermis and target deeper cellular structures, such as the sebaceous gland, without damaging the surrounding dermis. No adverse events were reported during the course of either the SH study or SK study, explains a media release from Tosk Communications.
The Sebaceous Hyperplasia clinical study enrolled 73 patients, over the course of 2 months, each with up to four facial lesions. Patients received one or two non-thermal NPS treatments per lesion at five centers in the US. The study’s primary success measurement was the degree of clearing of benign SH lesions as rated by the investigator at the final study visit. Since these lesions frequently appear on the face, another important outcome assessment was the return of the skin’s normal appearance after the lesion was removed.
99.5% of the treated lesions were assessed as clear or mostly clear by investigators at the 60-day post-treatment follow-up evaluation. Approximately 92% (n=203) of treated lesions were assessed as clear or mostly clear after a single NPS treatment. Patients rated 78% of lesion outcomes at study end as satisfied or mostly satisfied. In some cases, mild to moderate post-treatment hyperpigmentation was noted, particularly in patients with higher Fitzpatrick Skin Types, the release explains.
“We are very excited about our NPS study findings and those of the other four centers because we see many patients in the clinic with Sebaceous Hyperplasia who opt out of treatment simply because current thermal-based modalities lack reliable efficacy and pose a high risk of damaged skin in the treated area,” says Gilly S. Munavalli, MD, a cosmetic and Mohs skin cancer surgeon in Charlotte, NC.
“Based on our cumulative clinical experience, NPS represents a reliable and consistent treatment that not only successfully eliminates bothersome SH lesions, but also addresses the underlying cause of the condition by treating the sebaceous gland that resides in the dermis while sparing surrounding non-cellular skin tissue,” Munavalli continues, further noting that “this added benefit of NPS helps reduce oil or sebum production that can contribute to other skin problems like acne.”
[Source(s): Tosk Communications, Business Wire]