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NCT Number: NCT07384078

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

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.

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Key information

Conditions

Superficial Basal Cell Carcinoma BCC BD Bowen's Disease Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Nodular Basal Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HUS Iho- ja allergiasairaala

Helsinki, 00250, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Focused Ultrasound

Device

High intensity focused ultrasound

Other names: HIFU

cryotherapy

Procedure

Liquid nitrogen cryotherapy

Other names: CRYO

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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)

  9. 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

Other outcomes

  1. Treatment costs

    Time frame: From treatment to the control at 4 weeks

    Time and resources required on treatment, cost effectiveness analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Investigator

CONTACT

[email protected]

+358401986550

Clinical Investigator

CONTACT

[email protected]

+358504287980

Sponsors and collaborators

Lead sponsor

Jussi Salonen

Other

Collaborators

  • HUS Skin and Allergy Hospital

Registry information

Official study title

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

Acronym: HIFUvsCRYO

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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