Dignitana has secured expanded approval from the US Food and Drug Administration (FDA) for its DigniCap cooling system to reduce hair loss (alopecia) during chemotherapy.
The system is claimed to the first cooling cap approved by the FDA for use in cancer patients with solid tumors
The company has developed DigniCap cooling system to reduce the frequency and severity of hair loss during chemotherapy in solid tumor cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used.
DigniCap is a computer-controlled system used during treatment. A cap will be placed on the head and liquid will be circulated to a cap to cool the scalp during chemotherapy treatment.
The cap is said to be covered by a second cap made from neoprene, a type of rubber that keeps the cooling cap in place and serves as an insulation cover to prevent loss of cooling.
The cooling will help to constrict blood vessels in the scalp, which decreases the amount of chemotherapy that reaches cells in the hair follicles.
In addition, the cold temperature reduces the activity of the hair follicles and decelerates down cell division.
In 2015, the DigniCap system secured approval for use in patients with breast cancer.
The approval was based on study, which included 122 Stage I and Stage II women with breast cancer who were undergoing chemotherapy.
The study showed that around 66% of patients treated with the DigniCap reported losing less than half their hair.
FDA Center for Devices and Radiological Health’s surgical devices division head Dr Binita Ashar said: “We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss.
“Managing the side effects of chemotherapy is a critical component to overall health and quality of life.”
Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.