A new dermatology clinical trial (NCT05133427) that uses focused ultrasound to treat non-nodular or recurrent basal cell carcinoma (BCC) has begun in Denmark. Unlike melanoma, BCC is a common type of skin cancer that is found in areas of the skin exposed to the sun. Although it is rarely fatal, it is the most common cancer worldwide. Traditional treatments include various types of surgical removal, radiation, photodynamic therapy, or topical medications.
The principal investigator is Professor Joergen Serup, MD, a dermatologist who will lead the study at Bispebjerg and Roskilde Hospitals, part of the University of Copenhagen. Up to 40 participants will be treated with the TOOsonix System ONE-M device. Each treatment consists of one to two minutes of HIFU applied to the affected area of skin.
“HIFU has a significant potential for future use in treatment of BCC and other dermatological conditions,” said Prof. Serup. “In experimental work, it has already been indicated that the device has important practical and resource-saving advantages over photodynamic therapy, which is a leading therapy in superficial and early-stage BCC. Noteworthy is the reduced pain-level during treatment…The method can work well in hospitals as well as private practice settings.”
No anesthesia or special after care is needed beyond regular follow-up visits for the first year after treatment. Initial safety and cure rate data will be reported after all participants have been followed for the first three months.