Pulse Biosciences, Inc. says the first patients have been treated in its multi-center study to evaluate the safety and efficacy of its Nano-Pulse Stimulation (NPS) technology for eliminating Sebaceous Hyperplasia (SH). SH is an unsightly benign skin lesion that typically appears on facial skin and is considered a difficult-to-treat condition with current modalities. NPS is a non-thermal technology that utilizes ultra-short, nanosecond pulsed electrical fields to directly affect cell membranes and intracellular structures while sparing non-cellular tissues.
A previously published study of NPS in the treatment of seborrheic keratosis skin lesions in 58 patients provided the first human evidence that NPS’ mechanism of action is well suited to target a broad range of difficult-to-treat benign and non-benign skin lesions by targeting the cellular structures of lesions, while sparing the surrounding non-cellular dermal layer of skin. The sparing of surrounding non-cellular skin tissues enables the treatment of deeper cellular structures in the skin such as the sebaceous glands that cause SH lesions.
According to one of the study’s principal investigators, Gilly Munavalli, MD, “The unique potential of NPS to target the overactive sebaceous glands that cause these unsightly lesions without damaging the surrounding dermal tissue shows great promise in treating a common problem that my patients ask about every day.” A renowned dermatologic and Mohs skin cancer surgeon, Dr. Munavalli is the medical director and founder of Dermatology, Laser & Vein Specialists of the Carolinas in Charlotte, NC.
Sebaceous Hyperplasia is a common benign skin condition caused by cellular sebaceous glands in the deeper dermal layer of the skin that become enlarged with an oily liquid called sebum, which creates unsightly bulges, or lesions on the surface of the skin. They present as single or multiple bulges that are yellowish, shiny, small papules or bumps with a depressed center and a yellow or white outer rim. If the oily facial bumps are unsightly or embarrassing, patients often choose to have them treated for the benefit of improved skin appearance. Sebaceous hyperplasia is estimated to affect 1% of the healthy U.S. population.
Sebaceous Hyperplasia Study Design
The prospective multicenter study of the Pulse Biosciences NPS device in the treatment of SH is expected to enroll up to a total of 60 patients at five leading medical centers across the United States that specialize in the treatment of skin diseases. Patients with a minimum of two SH lesions and up to five lesions will be enrolled and followed for a 60-day period. The study’s primary success measurement is 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 is the return of normal appearance of the skin after the lesion is cleared. Details can be found on ClinicalTrials.gov.
Pulse Biosciences expects to complete the study by the end of 2018. In addition to Dr. Gilly Munavalli, other principal investigators include facial plastic surgeon James Newman, MD in San Mateo, CA; and dermatologists, Thomas Rohrer, MD in Boston; Suzanne Kilmer, MD in Sacramento: and Brian Zelickson, MD in Minneapolis.
“We are pleased to begin the next clinical study of our Nano-Pulse Stimulation technology for the treatment of Sebaceous Hyperplasia,” said Darrin Uecker, President and CEO of Pulse Biosciences. “We believe this study is an important next step in developing our portfolio of dermatology applications and the opportunity to further demonstrate the excellent safety profile and favorable patient experience of NPS treatments as we look to progress our NPS platform into non-benign applications.”
Ed Ebbers, Vice President and General Manager of Dermatology at Pulse Biosciences added: “Today’s announcement marks the second dermatology clinical program we’ve initiated to evaluate the efficacy of our novel NPS treatment technology. In collaboration with leading skin experts, we hope to prove the broad ability of NPS to target cellular lesions while sparing the surrounding dermal tissue as a unique and valuable mechanism for treating benign and non-benign lesions, particularly the deeper lesions that are hard to treat with available medical options.”