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News From the Food and Drug Administration
January 19, 2016

Cooling System to Prevent Hair Loss

Author Affiliations

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(3):243. doi:10.1001/jama.2015.18375

Women with breast cancer who dread losing their hair during chemotherapy have a new ally. The first computer-controlled scalp cooling device designed to reduce the frequency and severity of chemotherapy-induced alopecia has gained FDA approval.

The DigniCap Cooling System, manufactured by Dignitana of Lund, Sweden, circulates liquid coolant throughout a silicone cap that fits snugly over the head. The cap contains 2 sensors that continuously monitor scalp temperature, allowing the system to maintain the optimal cooling level. A third built-in safety sensor prevents scalp temperature from dropping below 32°F. In a clinical study, patients’ scalp temperature was lowered to between 37.4°F and 41°F (Friedrichs K and Carstensen MH. Springerplus. 2014;3:500). An insulating outer cap made of neoprene fits over the silicone cap and keeps it in place while patients receive therapy.