The DigniCap reaches temperatures near freezing, causing capillaries at the scalp to vasoconstrict, or tighten to reduce blood flow. This is the body’s natural reaction to cold, as it tries to warm the blood by keeping it closer to the body’s core, and further from the cold source.
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.
“For the past several years, we’ve worked closely with Dignitana to conduct rigorous clinical trials that demonstrate the safety and effectiveness of the DigniCap system,” says Dr. Hope S. Rugo, Director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center. “This FDA clearance means that for many cancer patients in the U.S., chemo-induced hair loss will no longer be a distressing concern.”
The device has only been tested and approved for breast cancer patients; use for treatment of other cancers has yet to be tested.