Dignitana, a company out of Lund, Sweden, won FDA de novo clearance for its DigniCap hair loss prevention device to be used for women with breast cancer undergoing chemotherapy. The technology has been widely reported on in the media over the last couple of years and the FDA clearance makes it the first such product on the U.S. market. The system has already seen substantial use overseas with positive results.
The DigniCap cools the scalp during chemo thanks to a control unit pumping a cold fluid through the cap. The temperature is carefully controlled via sensors within the cap, with a safety mechanism preventing it dropping below freezing point, and can be moderated using a touchscreen display. Because the scalp is cooled, the vessels constrict, lowering the amount of chemo that can pass through. Meanwhile, the slower cellular metabolism caused by lower temperatures minimizes the uptake of chemo agents into the hair follicles.
Some details from the study that led to the regulatory clearance:
In the U.S. clinical trial 7 out of 10 patients with early stage breast cancer kept at least 50% of their hair. With regards to safety, no severe adverse events were reported. While most patients had a feeling of chilliness during the cooling down period only 3 out of 106 trial participants discontinued for this reason. A patient reported satisfaction score (ranked from 0 to 100, with 100 being “completely satisfied”), showed a mean score of 87.5 satisfaction with the decision to use scalp cooling, a mean score of 70.9 for hair quantity, and a mean score of 69.1 for satisfaction with hair quality. In the U.S. trial, scalp cooling was evaluated mainly on regimens including taxanes (such as paclitaxel and docetaxel) but outside of the U.S. there is also experience from scalp cooling with anthracyclines (such as epirubicin and doxorubicin).
Flashback: DigniCap to Help Prevent Chemo Caused Hair Loss Cleared for FDA Trial…
Product page: DigniCap…
Source: Dignitana…