High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease in Adults (HIFUvsCRYO)

Jussi Salonen

Status: Begins enrollment in 1 month

Conditions: Superficial Basal Cell Carcinoma; BD; BCC; Bowen's Disease; Nodular Basal Cell Carcinoma

Treatments: Procedure: Cryotherapy; Device: High Intensity Focused Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT07384078

HUS/6520/2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 294 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Gorlin Golz syndrome
• Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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294 participants in 3 patient groups

sBCC

Experimental group

Description:

Superficial basal cell carcinoma

Treatment:

Device: High Intensity Focused Ultrasound

Procedure: Cryotherapy

nBCC

Experimental group

Description:

Nodular basal cell carcinoma

Treatment:

Device: High Intensity Focused Ultrasound

Procedure: Cryotherapy

BD

Experimental group

Description:

Bowen's disease

Treatment:

Device: High Intensity Focused Ultrasound

Procedure: Cryotherapy