Dignitana Inc. recently announced that the DigniCap scalp cooling system, which was cleared by the U.S. Food and Drug Administration (FDA) in December 2015 to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, is now available at 10 cancer treatment centers across the United States. Scalp cooling is administered alongside chemotherapy in medical infusion centers.
The DigniCap system is the first and only scalp-cooling device to complete FDA clinical trials in the United States, where 7 out of 10 patients with early-stage breast cancer kept at least 50% of their hair.
The DigniCap scalp-cooling system features a patented tight-fitting silicone cooling cap that is placed directly on the head and an outer neoprene cap that insulates and secures the silicone cap. The cooling cap is connected to a cooling and control unit with touch-screen prompts. A liquid coolant circulates throughout the silicone cap, delivering consistent and controlled cooling to all areas of the scalp. The cap is fitted to the head, and the temperature of the scalp is lowered, resulting in vasoconstriction with reduced delivery of chemotherapy to the scalp, as well as reduced cellular uptake of drugs due to decreased intrafollicular metabolic rate. These factors together reduce the risk of chemotherapy-induced hair loss.
The following cancer treatment centers will be the first 10 sites in the United States to provide the DigniCap scalp-cooling system in their breast cancer treatment regimens:
Hope Rugo, MD, of UCSF’s Helen Diller Family Comprehensive Cancer Center, Principal Investigator for the FDA multicenter clinical trial of the DigniCap, and Susan Melin, MD, of Wake Forest Baptist, Principal Investigator of the DigniCap trial at her institution, originated early clinical trials and shepherded studies throughout the FDA process. ■