FDA grants clearance to Dignitana’s cooling system for alopecia


The US Food and Drug Administration (FDA) has granted expanded clearance for the use of Sweden-based firm Dignitana’s DigniCap cooling system to minimise hair loss (alopecia) during chemotherapy.

DigniCap is a computer-controlled cooling system that supplies liquid to a cap worn on the head to cool the scalp during chemotherapy.

The system decreases the frequency and severity of hair loss in solid tumour patients who are treated with chemotherapeutic agents and doses that might lead to alopecia.

FDA Centre for Devices and Radiological Health Surgical Devices division director said: “We are pleased to expand the use of this product for cancer patients with solid tumours to potentially minimise chemotherapy-induced hair loss.”

The cap used during the procedure is covered by another neoprene-made cap to hold the cooling cap in place and to provide insulation.

"The results reportedly indicated that there was a loss of less than half of the hair in 66% of the patients."

The cooling technique is expected to constrict the scalp’s blood vessels, minimising the hair follicles activity, cell division, and the chemotherapy amount reaching the follicles.

Originally, DigniCap was authorised by the FDA in 2015 for use in breast cancer patients.

The authorisation was based on the validation of the cooling system’s efficacy performed in 122 Stage I and Stage II breast cancer patients receiving chemotherapy treatment with agents known to cause hair loss.

The results reportedly indicated that there was a loss of less than half of the hair in 66% of the patients.

To support its expanded indication for the device, the firm has submitted peer-reviewed articles analysing DigniCap application in patients with solid tumours other than breast cancer.