About this trial
This prospective, randomized, controlled, and single-blinded non-inferiority clinical trial compare the efficacy and tolerability of high intensity focused ultrasound (HIFU) to standard cryotherapy in the treatment of low-risk basal cell carcinomas (BCCs) and Bowen's disease (BD) in adults. The main questions it aims to answer are:
* Is HIFU an efficient treatment option for BCCs and BD? * What medical problems do participants get after HIFU?
Researchers will compare HIFU to standard cryotherapy with liquid nitrogen to see if the ultrasound works to treat these local and low-risk non-melanosytic skin cancers.
Participants will:
* Be treated either with HIFU (intervention) or cryotherapy (control). * Visit the clinic 4 weeks, 1-, 3- and 5 years after the treatment for check-ups, tests and survey questions.
Eligibility criteria
Qualifiers
age 18 years or older at the time of informed consent
ability to give informed consent and comply with the treatment protocol and follow-up plan
study lesion located between neck and knees
one of following histologically confirmed diagnosis: Superficial BCC with maximum diameter of 2.0 cm / Nodular BCC with max. diameter of 1.5 cm / BD with max. diameter of 2.0 cm
Disqualifiers
Study lesion location in face, head, genitals, hands, or below the knee
Clinical/dermoscopical/histological feature for high-risk/aggressive BCC
Clinical/histological sign for hypertrophic BD
Clinical/dermoscopical/histological feature for Squamous cell carcinoma
Trial design
Treatments tested in this trial
- High Intensity Focused Ultrasound
- Cryotherapy
Treatment groups
Sponsors and collaborators
Jussi Salonen
Lead sponsor
Helsinki University Central Hospital
Sponsor institution
HUS Skin and Allergy Hospital
Collaborator