FDA Approval Finally Comes Through For Women’s Hair Loss Treatment

General Hair Loss, Hair Loss News

FDA approval takes time, it requires a great deal of detailed research and study of research before any new medicinal product is approved for the market. In this case it was a cooling cap aimed at reducing the effects of chemotherapy drugs on hair loss. Given that the only FDA approved drug currently on the market is only available to men the news is particularly positive for women. Combine that absence of FDA approved drugs with the social consequence for a woman suddenly losing most of her hair and you have a potentially desperate situation, where not only is the sufferer losing her hair but she has to cope with everyone knowing she is unwell… removing the possibility of privacy through an incredibly difficult period. Womens hair loss and its treatment is woefully under-served, we take a closer look at this important addition.

How Does It Work?


The cooling cap has in fact been around for decades in one form or another, though as you might expect the technology has seen the system improve exponentially during that time. The system that has been cleared for use. the Dignicap, if manufactured in Sweden by Dignitana AB.

Half an hour prior to treatment the snug fitting cap is fitted, it cools the scalp to just above freezing reducing blood flow to the follicles – thereby reducing their exposure to the harmful cancer treating drugs. The cap remains in place for up to 90 minutes after the procedure while the levels of those drugs in the blood reduce.

Clinical Trial

clinical trial

The FDA study involved five different medical centres and involved a total of 122 women, all of them being treated with the standard regimen for early stage breast cancer. In these tests over half of the women retained over half their hair, a significant improvement on the retention achieved without the cooling cap.

Cancer treatment clinics have become used to women arriving for their procedures carrying freezer bags containing multiple cooling caps – the lack of FDA approval meant this was their only choice, and because one cap would not last the necessary length of time they would need to bring an appropriate number of extra caps.

Hats off (caps on!)

Image result for doff your cap public domain

Our hearty congratulations go out to the team at Dignitana AB, they will be leasing their cooling cap to clinics meaning the treatment will be available as part of the chemotherapy procedure, and of course that it will be administered and maintained by the professional medical team there.

We welcome this important step forward for the thousands of women who have to endure chemotherapy every year, and hope that the availability of the cooling cap will mean many more retain the option for privacy through their treatment.





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