The U.S. Food and Drug Administration (FDA) has cleared marketing of the Paxman Scalp Cooling System, a scalp cooling technology that was developed to reduce hair loss in breast cancer patients undergoing chemotherapy.

The approval is based on the same results presented at San Antonio Breast Cancer Symposium 2016.

This approval follows the approval of a similar device late in 2015.

The concept came when the mother of four, Sue Paxman, experienced first-hand the trauma of chemotherapy-induced hair loss.

“Hair loss is consistently ranked in the top five most distressing cancer chemotherapy side effects,” explains Richard Paxman, CEO.

The prevention of hair loss represents an important challenge in oncology, which affects over four million patients annually. By 2030 it is estimated it will affect over 6.7 million patients every year.

The damage that chemotherapy causes to the hair follicle can be alleviated by using scalp cooling, also known as the 'cold cap.'

Scalp cooling works by reducing the temperature of the scalp by a few degrees immediately before, during and after the administration of chemotherapy.

There are a number of mechanisms by which cooling protects the hair follicles: vasoconstriction reduces the amount of chemotherapy that reaches the hair follicles, reduced drug diffusion through the cell membrane, decreased cell division, reduced active transport mechanisms, and a general reduction in metabolic activity.

“Like my mum, many people find hair loss to be extremely traumatic." Paxman continued "It is estimated that 8% of patients actually refuse chemotherapy because they do not want to lose their hair. After experiencing this first hand, we have been determined to change this, and help

As part of the FDA clearance process, the scalp cooler was used in the first-ever randomised clinical trial to evaluate modern scalp cooling, which took place at a number of sites including Baylor College of Medicine, Memorial Sloan Kettering, the U.S. Oncology Network, Cleveland Clinic & Summit Medical Group - MD Anderson Cancer Center.

The multi-center prospective study, which involved 186 women across New Jersey, New York, Texas, and Ohio, revealed that the cold cap preserved hair in more than 50% of the women who used it.

Speaking about results lead researcher Dr. Julie Nangia, MD, Assistant Professor of Medicine at Baylor College of Medicine, Houston, Texas, USA added: “The Paxman Hair Loss Prevention System is a safe and effective method for reducing hair loss in women being treated with chemotherapy for breast cancer, especially for those on taxane-based regimens.”

“Hopefully in five years from now, we will consider scalp cooling part of routine practice, the same way that we can see an IV-pump with an IV-pole as part of the regular equipment you would expect in an infusion suite. It’s important that people undergoing chemotherapy understand what scalp cooling is and that it is an option available to them if they want to prevent hair loss.”

Source: Paxman & JAMA