NCT07384078

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

HIFU vs. CRYO - High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease - a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 294 (estimated)
• Sponsor: Jussi Salonen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Superficial Basal Cell Carcinoma
• Nodular Basal Cell Carcinoma
• Bowen's Disease
• BCC
• BD

Interventions

Type	Name	Description
DEVICE	High Intensity Focused Ultrasound	High intensity focused ultrasound
PROCEDURE	Cryotherapy	Liquid nitrogen cryotherapy

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-12-31
• Completion: 2032-12-31
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: Finland