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.
Low-risk BCCs and BD are both local keratinocyctic skin cancers with increasing prevalence and they cause a rising burden to the health care system. In this study we assess the efficacy of HIFU compared to liquid nitrogen cryotherapy between years 2025-2030. Alltogether 294 patients are recruited based on referrals or from patients attending the clinic, with histologically confirmed BD, superficial BCC or nodular BCC located between neck and knees. 98 tumors of each aforementioned subtypes will be recruited and randomized with 1:1 ratio to HIFU and CRYO - groups. Follow-up appointments are 4 weeks, 1-, 3- and 5 years post treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
294
High intensity focused ultrasound
Liquid nitrogen cryotherapy
HUS Iho- ja allergiasairaala
Helsinki, Finland
Treatment efficacy
Histologically confirmed recurrence-free survival assessed at 1, 3 and 5 years after treatment. Recurrence during follow up: Yes/no.
Time frame: From treatment to the end of follow up at 5 years
Pain during treatment assessed by NRS
Zero is equivalent to no pain and 10 indicates the worst possible pain
Time frame: Pain during treatment procedure on treatment visit
Pain after treatment previous 4 weeks NRS
Zero is equivalent to no pain and 10 indicates the worst possible pain
Time frame: From treatment to the control visit at 4 weeks
Post treatment reactions assessed by both observer and patient
Yes/no: crust, ulceration, erosion, erythema, oozing, infection
Time frame: From treatment to the control visit at 4 weeks
Healing result assessed by both observer and patient
Healed (defined as no ulcer/crust left)? Yes/no
Time frame: From treatment to the control visit at 4 weeks
Healing time assessed by patient. How many weeks ago?
If defined as healed by the patient.
Time frame: From treatment to the control visit at 4 weeks
Cosmetic outcome assessed by both observer and the patient
Poor/fair/goof/excellent
Time frame: From 1 year control to the end of follow up at 5 years
Patient satisfaction inquiry, modified 6 questions
Patients will be asked about an overall satisfaction with the provided treatment, recommendation of the received treatment to other patients, readiness to undergo the same treatment again and post-treatment recovery and its impact on daily life. Answers will be evaluated with a modified NRS-scale from 0 to 10
Time frame: From 1 year control to the end of follow up at 5 years
Scarring after treatment POSAS 2.0
Patient and Observer Scar Assessment Scale (POSAS 2.0)
Time frame: From 1 year control to the end of follow up at 5 years
Other adverse events related to the given treatment
Separate inquiry of adverse events
Time frame: From treatment visit to the end of follow up at 5 years
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