Second Scalp Cooling Device to Prevent Chemotherapy-Induced Alopecia Seeks FDA Approval

A medical device company in the United Kingdom, Paxman, has announced the submission of clinical evidence for its Paxman Scalp Cooling System, for regulatory clearance by the FDA. The company is seeking approval for using the device as an intervention to prevent chemotherapy-induced alopecia in women undergoing specific chemotherapy treatment for breast cancer.

The company, a pioneer in the field of scalp cooling, has over 2 decades of global experience. According to the company website, clinical trials that incorporated Paxman as a preventive intervention were quite effective—43% to 93.7%—in preventing hair loss following chemotherapy. In the United States, Paxman has partnered with Baylor Breast Cancer Center for a phase 3 trial to measure success in hair preservation (CTCAE v 4 alopecia grade less than 2) as the primary outcome. The secondary outcomes measure of the trial, with a time frame of 4 to 8 months, is improved quality of life, to be measured every 2 to 3 weeks after every course of chemotherapy.

Initiated in December 2013, the study is expected to be completed by December 2018. Newly diagnosed patients with stage 1 or 2 breast cancer, undergoing anthracycline- or taxane-based chemotherapy regimens, are eligible to participate in the trial. The company has also partnered with other cancer treatment centers within the United States, including Cleveland Clinic, Memorial-Sloan Kettering Cancer Center, Carol G. Smith Cancer Center in Morristown, NJ, and several US Oncology sites, according to a company press release. And it is data from these studies that was presented at the recently concluded San Antonio Breast Cancer Symposium and also submitted to the FDA.

The release states that 50.5% of women in the scalp cooling group had hair preservation, compared with 0% in the control no cooling group. This led the researchers, led by Julie Nangia, MD, assistant professor of medicine at Baylor College of Medicine, Houston, to stop the trial early.

If approved, Paxman will be just the second scalp cooling device to be cleared for marketing by the FDA. Digitana Inc’s DigniCap was cleared in December 2015.