FDA Clears Marketing Approval for Device to Reduce Hair Loss during Chemotherapy

Posted on January 4th, 2016 by

The United States Food and Drug Administration (FDA) cleared for marketing the first cooling cap to reduce hair loss due to chemotherapy.

The cooling cap (Dignitana DigniCap Cooling System) is to be used for female breast cancer patients who are undergoing chemotherapy.

Certain types of chemotherapy are strongly associated with causing hair loss, whereupon hair may gradually start to fall out either all over or in section; it may become thin; or it may fall out entirely.

Breast cancer patients have stated that hair loss (alopecia) reduces their quality of life while undergoing treatment, as they often feel that they appear to others as a “cancer patient”, requiring uncomfortable wigs and/or hats and scarves to cover a bald head.

The DigniCap is a type of cap that is placed on a patient’s head during chemotherapy treatment. A cool liquid is circulated through the cap, while a neoprene cover maintains insulation to keep the cool temperatures within the cap.

The cold temperatures constrict the blood vessels, reducing the amount of chemotherapy which causes the hair loss, from reaching the hair follicles. Furthermore, the cool temperatures reduce the division of the cells of the hair follicles. This is important as chemotherapy tends to kill cells that are rapidly dividing.

In the press release announcing the marketing clearance for the cooling cap, William Maisel, M.D., M.P.H, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health stated, “We are pleased to see a product for breast cancer patients that can minimize chemotherapy-induced hair loss and contribute to the quality of life of these individuals. Managing the side effects of chemotherapy is a critical component to overall health and recovery.”

The study recently conducted to evaluate the effectiveness of the cooling cap included 122 women with early stages of breast cancer who were undergoing chemotherapy that was associated with causing hair loss.

Approximately 3-6 weeks after the last chemotherapy cycle, over 66% of patients treated with the cooling cap reported losing less than half their hair.

The most common side effects associated with the cooling cap were cold-induced headaches, neck and should discomfort, chills, and pain associated with wearing the device for extended periods of time.

Reference: United States Food and Drug Administration. FDA news release. FDA allows marketing of cooling cap to reduce hair loss during chemotherapy. Accessed December 12, 2015. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476216.htm.

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Tags: alopecia, Breast Cancer, digitana Dignicap Cooling System, fda, hair loss, News

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