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

January 26, 2026 updated by: Jussi Salonen

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

294

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Helsinki, Finland, 00250
        • HUS Iho- ja allergiasairaala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sBCC
Superficial basal cell carcinoma
Device: High Intensity Focused Ultrasound
High intensity focused ultrasound
Other Names:
  • HIFU
Procedure: Cryotherapy
Liquid nitrogen cryotherapy
Other Names:
  • CRYO
Experimental: nBCC
Nodular basal cell carcinoma
Device: High Intensity Focused Ultrasound
High intensity focused ultrasound
Other Names:
  • HIFU
Procedure: Cryotherapy
Liquid nitrogen cryotherapy
Other Names:
  • CRYO
Experimental: BD
Bowen's disease
Device: High Intensity Focused Ultrasound
High intensity focused ultrasound
Other Names:
  • HIFU
Procedure: Cryotherapy
Liquid nitrogen cryotherapy
Other Names:
  • CRYO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment efficacy
Time Frame: From treatment to the end of follow up at 5 years
Histologically confirmed recurrence-free survival assessed at 1, 3 and 5 years after treatment. Recurrence during follow up: Yes/no.
From treatment to the end of follow up at 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during treatment assessed by NRS
Time Frame: Pain during treatment procedure on treatment visit
Zero is equivalent to no pain and 10 indicates the worst possible pain
Pain during treatment procedure on treatment visit
Pain after treatment previous 4 weeks NRS
Time Frame: From treatment to the control visit at 4 weeks
Zero is equivalent to no pain and 10 indicates the worst possible pain
From treatment to the control visit at 4 weeks
Post treatment reactions assessed by both observer and patient
Time Frame: From treatment to the control visit at 4 weeks
Yes/no: crust, ulceration, erosion, erythema, oozing, infection
From treatment to the control visit at 4 weeks
Healing result assessed by both observer and patient
Time Frame: From treatment to the control visit at 4 weeks
Healed (defined as no ulcer/crust left)? Yes/no
From treatment to the control visit at 4 weeks
Healing time assessed by patient. How many weeks ago?
Time Frame: From treatment to the control visit at 4 weeks
If defined as healed by the patient.
From treatment to the control visit at 4 weeks
Cosmetic outcome assessed by both observer and the patient
Time Frame: From 1 year control to the end of follow up at 5 years
Poor/fair/goof/excellent
From 1 year control to the end of follow up at 5 years
Patient satisfaction inquiry, modified 6 questions
Time Frame: From 1 year control to the end of follow up at 5 years
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
From 1 year control to the end of follow up at 5 years
Scarring after treatment POSAS 2.0
Time Frame: From 1 year control to the end of follow up at 5 years
Patient and Observer Scar Assessment Scale (POSAS 2.0)
From 1 year control to the end of follow up at 5 years
Other adverse events related to the given treatment
Time Frame: From treatment visit to the end of follow up at 5 years
Separate inquiry of adverse events
From treatment visit to the end of follow up at 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment costs
Time Frame: From treatment to the control at 4 weeks
Time and resources required on treatment, cost effectiveness analysis
From treatment to the control at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jussi Salonen

Collaborators

HUS Skin and Allergy Hospital

Investigators

  • Principal Investigator: Sari Koskenmies, Head of Department, Helsinki University Hospital, Skin and Allergy Hospital, Dermatologic procedure unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/6520/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The informed consent obtained from participants does not include permission for sharing individual-level data with external researchers. Also, data sharing is restricted due to institutional and contractual agreements that do not permit external distribution of individual-level data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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