The DigniCap is a scalp-chilling device that’s clinically proven to reduce hair loss in cancer patients during chemotherapy. The helmet-like device, developed by Dignitana, is the first of its kind to be cleared in the United States by the Food and Drug Administration.
Chemotherapy drugs cause hair loss because they are quickly metabolized by rapidly proliferating cells, including those found in hair follicles. By reaching temperatures near freezing, the DigniCap induces capillaries at the scalp to vasoconstrict, or tighten, to reduce blood flow. This natural reaction to the cold is exploited to inhibit drugs in the bloodstream from reaching the cells in the hair follicles. In addition, the cold temperature reduces cellular metabolism at the hair follicles, so that they intake a lesser amount of drugs that would otherwise harm them.
The cap consists of a tightfitting silicone cap with a neoprene insulating outer cap. With two sensors that offer continuous scalp-temperature monitoring, the user can control the cooling system via a touchscreen display. Gradual cool-down reduces discomfort and a safety mechanism prevents the hat from reaching temperatures below freezing.
Clinical trials from several medical centers show that 7 out of 10 patients with early-stage breast cancer saw at least a 50% reduction in hair loss. A mean score of 87.5% was measured among patients in their satisfaction with DigniCap, and a mean score of 69.1% was measured for hair-quality satisfaction. Only three out of 106 participants dropped out of the trial because they felt too cold during or after the treatment.
The video below describes the FDA-approved device.