Pulse Biosciences, Inc’s CellFX Nano-Pulse Stimulation system cleared more than 90 percent of sebaceous hyperplasia (SH) lesions in a study presented at the 2019 American Academy of Dermatology (AAD) Annual Meeting in Washington, DC.
Specifically, more than 99.5 percent of SH lesions treated with the investigational technology were rated as clear or mostly clear by investigators 60 days after treatment, the study showed.
NPS is a non-thermal technology that utilizes ultra-short, nanosecond energy pulses to orchestrate a regulated cell death while sparing acellular tissue. This new study builds upon earlier work showing the system’s safety and efficacy in the treatment of Seborrheic Keratosis lesions.
The SH clinical study enrolled 73 patients, over the course of two months, each with up to four facial lesions. Patients received one or two non-thermal NPS treatments per lesion at five centers in the U.S. 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 outcome assessment was the return of the skin’s normal appearance after the lesion was removed.
Approximately 92 percent (n=203) of treated lesions were assessed as clear or mostly clear after a single NPS treatment. Patients rated 78 percent 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 study showed.