A cold cap company which makes scalp-chilling devices to try and help people avoid hair loss during cancer treatment is to start a Phase 2 trial in the US.
While it has not expressly been said, it seems likely that the maker is trying to get FDA approval which would bring it in line with two other scalp cooling system manufacturers which have already been granted this status in the USA.
The study is slated to start in November and will feature the Penguin cold cap in a clinical trial that is overseen by Providence Health & Services, with Medical Specialties of California listed as a collaborator; Medical Specialties of California is an organisation that appears to be closely associated with Penguin and was founded in 1998 to “further research and develop a specialised system of scalp cooling.”
Indeed, the FDA archives include a letter to Medical Specialties of California dated August 15, 2016 which begins: “The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Penguin Cold Cap in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act.”
FDA approval would likely make a significant difference in the marketing of the product, and put it on more of an even keel with UK company Paxman and Swiss enterprise Dignitana Inc, makers of a device called the DigniCap.
The clinical trial into the Penguin cold cap will see an estimated 80 volunteers with breast cancer using the device for at least 50 minutes before chemotherapy infusion begins. They will wear it during the treatment and for four hours afterwards at test centres that have yet to be announced but seem set to be in Portland, Oregon.
Thirty days following treatment any hair loss will be assessed, and volunteers will also be asked to complete questionnaires about their quality of life, their body image, and whether or not they thought it had been worth using the cold cap. The completion date for the study is expected to be the summer of 2020.
Penguin says that its cap is a portable scalp cooling system which uses gel-filled cold caps that are cooled on dry ice and exchanged every 30 minutes in order to maintain optimum temperature. On its website, it states that: “Its unique crylon gel formula is specifically created to maintain cold temperatures for much longer periods of time than other conventional cooling gels and foams. No scalp preparation is required before use.”
Cold caps don’t work all of the time, but the makers of both the Paxman and DigniCap devices claim high success rates. It is worth pointing out, though, that success is widely perceived as being when someone keeps enough hair to not need to wear a wig.
The way the devices work is by chilling the scalp so that cancer drugs which travel in the blood to that region have less chance of reaching follicles and damaging them.
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