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Superficial Basal Cell CarcinomaHIFUvsCRYONCT07384078

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

A study testing High Intensity Focused Ultrasound and Cryotherapy in people with Superficial Basal Cell Carcinoma and Nodular Basal Cell Carcinoma, run by Jussi Salonen at 1 site in Finland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
High Intensity Focused Ultrasound and Cryotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
294 participants
Where
1 siteFinland
Study dates
1 Apr 2026to 31 Dec 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Investigator contact

+358401986550

jussi.salonen@hus.fi

Clinical Investigator contact

+358504287980

mari.salmivuori@hus.fi

Finland1 site

  • HUS Iho- ja allergiasairaala

    Helsinki, 00250

Other trials in Finland

About this study

Official 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

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?
Read more

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.
Read the 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.

Being tested
High Intensity Focused Ultrasound, Cryotherapy
Keywords
HIFU, cryo, cryotherapy, high intensity focused ultrasound, basal cell carcinoma, Bowen's disease, superficial basal cell carcinoma, nodular basal cell carcinoma, non-surgical treatment
Medical subject headings
Bowen's Disease, Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Focused UltrasoundDevice

    Also called HIFU

    High intensity focused ultrasound

  • CryotherapyProcedure or surgery

    Also called CRYO

    Liquid nitrogen cryotherapy

Study groups in NCT07384078
Study groupRoleWhat they receive
sBCCExperimentalSuperficial basal cell carcinoma
Receives: Device: High Intensity Focused Ultrasound; Procedure: Cryotherapy
nBCCExperimentalNodular basal cell carcinoma
Receives: Device: High Intensity Focused Ultrasound; Procedure: Cryotherapy
BDExperimentalBowen's disease
Receives: Device: High Intensity Focused Ultrasound; Procedure: Cryotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment efficacy

    Histologically confirmed recurrence-free survival assessed at 1, 3 and 5 years after treatment. Recurrence during follow up: Yes/no.

    Measured: From treatment to the end of follow up at 5 years

Secondary outcomes (9)

  1. Pain during treatment assessed by NRS

    Zero is equivalent to no pain and 10 indicates the worst possible pain

    Measured: Pain during treatment procedure on treatment visit

  2. Pain after treatment previous 4 weeks NRS

    Zero is equivalent to no pain and 10 indicates the worst possible pain

    Measured: From treatment to the control visit at 4 weeks

  3. Post treatment reactions assessed by both observer and patient

    Yes/no: crust, ulceration, erosion, erythema, oozing, infection

    Measured: From treatment to the control visit at 4 weeks

  4. Healing result assessed by both observer and patient

    Healed (defined as no ulcer/crust left)? Yes/no

    Measured: From treatment to the control visit at 4 weeks

  5. Healing time assessed by patient. How many weeks ago?

    If defined as healed by the patient.

    Measured: From treatment to the control visit at 4 weeks

  6. Cosmetic outcome assessed by both observer and the patient

    Poor/fair/goof/excellent

    Measured: From 1 year control to the end of follow up at 5 years

  7. 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

    Measured: From 1 year control to the end of follow up at 5 years

  8. Scarring after treatment POSAS 2.0

    Patient and Observer Scar Assessment Scale (POSAS 2.0)

    Measured: From 1 year control to the end of follow up at 5 years

  9. Other adverse events related to the given treatment

    Separate inquiry of adverse events

    Measured: From treatment visit to the end of follow up at 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
294 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07384078
Sponsor's protocol ID
HUS/6520/2025
Acronym
HIFUvsCRYO
Status last verified
Jan 2026
First submitted
26 Jan 2026
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • The Finnish Cancer Registry; Syöpätilastosovellus. Vuosiraportti 2023. [Internet]. [cited 2025 Nov 19]. Available from: https://syoparekisteri.fi/tilastot/tautitilastot/

  • Schlessinger DI, Reynolds KA, Dirr MA, Ibrahim SA, Yanes AF, Lazaroff JM, Godinez-Puig V, Chen BR, Kurta AO, Cotseones JK, Chiren SG, Furlan KC, Iyengar S, Behshad R, DeHoratius DM, Denes P, Drucker AM, Dzubow LM, Etzkorn JR, Harwood CA, Kim JYS, Lawrence N, Lee EH, Lissner GS, Marghoob AA, Matin RN, Mattox AR, Mittal BB, Thomas JR, Zhou XA, Zloty D, Schmitt J, Kirkham JJ, Armstrong AW, Basset-Seguin N, Billingsley EM, Bordeaux JS, Brewer J, Brown M, Brown M, Collins SAB, Fargnoli MC, De Azevedo SJ, Dummer R, Eggermont A, Goldman GD, Haedersdal M, Hale EK, Hanlon A, Harms KL, Huang CC, Hurst EA, In GK, Kelleners-Smeets N, Kheterpal M, Leshin B, Mcdonald M, Miller SJ, Miller A, Mostow EN, Trakatelli M, Nehal KS, Ratner D, Rogers H, Sarin KY, Soon SL, Stasko T, Storrs PA, Tagliaferri L, Vidimos AT, Wong SL, Yu SS, Zalaudek I, Zeitouni NC, Zitelli JA, Poon E, Sobanko JF, Cartee TV, Maher IA, Alam M. Development of a core outcome set for basal cell carcinoma. J Am Acad Dermatol. 2022 Sep;87(3):573-581. doi: 10.1016/j.jaad.2022.04.059. Epub 2022 May 10.

    PubMed 35551965

  • Hansen JP, Drake AL, Walling HW. Bowen's Disease: a four-year retrospective review of epidemiology and treatment at a university center. Dermatol Surg. 2008 Jul;34(7):878-83. doi: 10.1111/j.1524-4725.2008.34172.x.

    PubMed 18363722

  • Wang I, Bendsoe N, Klinteberg CA, Enejder AM, Andersson-Engels S, Svanberg S, Svanberg K. Photodynamic therapy vs. cryosurgery of basal cell carcinomas: results of a phase III clinical trial. Br J Dermatol. 2001 Apr;144(4):832-40. doi: 10.1046/j.1365-2133.2001.04141.x.

    PubMed 11298545

  • Basset-Seguin N, Ibbotson SH, Emtestam L, Tarstedt M, Morton C, Maroti M, Calzavara-Pinton P, Varma S, Roelandts R, Wolf P. Topical methyl aminolaevulinate photodynamic therapy versus cryotherapy for superficial basal cell carcinoma: a 5 year randomized trial. Eur J Dermatol. 2008 Sep-Oct;18(5):547-53. doi: 10.1684/ejd.2008.0472. Epub 2008 Aug 8.

    PubMed 18693158

  • Seppä K, Lappi-Heikkinen S, Johansson S, Malila N, Pitkäniemi J. SYÖPÄ 2023 Tilastoraportti Suomen syöpätilanteesta. Suomen Syöpäyhdistys, Helsinki 2025.

  • Keratinocyte Cancer Clinical Guidelines | Cancer Council [Internet]. [cited 2025 Nov 19]. Available from: https://www.cancer.org.au/clinical-guidelines/skin-cancer/keratinocyte-cancer

  • Telfer NR, Colver GB, Morton CA; British Association of Dermatologists. Guidelines for the management of basal cell carcinoma. Br J Dermatol. 2008 Jul;159(1):35-48. doi: 10.1111/j.1365-2133.2008.08666.x.

    PubMed 18593385

  • Newlands C, Currie R, Memon A, Whitaker S, Woolford T. Non-melanoma skin cancer: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol. 2016 May;130(S2):S125-S132. doi: 10.1017/S0022215116000554.

    PubMed 27841126

  • Work Group; Invited Reviewers; Kim JYS, Kozlow JH, Mittal B, Moyer J, Olencki T, Rodgers P. Guidelines of care for the management of basal cell carcinoma. J Am Acad Dermatol. 2018 Mar;78(3):540-559. doi: 10.1016/j.jaad.2017.10.006. Epub 2018 Jan 10.

    PubMed 29331385

  • Bichakjian CK, Olencki T, Aasi SZ, Alam M, Andersen JS, Berg D, Bowen GM, Cheney RT, Daniels GA, Glass LF, Grekin RC, Grossman K, Higgins SA, Ho AL, Lewis KD, Lydiatt DD, Nehal KS, Nghiem P, Olsen EA, Schmults CD, Sekulic A, Shaha AR, Thorstad WL, Tuli M, Urist MM, Wang TS, Wong SL, Zic JA, Hoffmann KG, Engh A. Basal Cell Skin Cancer, Version 1.2016, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2016 May;14(5):574-97. doi: 10.6004/jnccn.2016.0065.

    PubMed 27160235

  • Peris K, Fargnoli MC, Kaufmann R, Arenberger P, Bastholt L, Seguin NB, Bataille V, Brochez L, Del Marmol V, Dummer R, Forsea AM, Gaudy-Marqueste C, Harwood CA, Hauschild A, Holler C, Kandolf L, Kellerners-Smeets NWJ, Lallas A, Leiter U, Malvehy J, Marinovic B, Mijuskovic Z, Moreno-Ramirez D, Nagore E, Nathan P, Stratigos AJ, Stockfleth E, Tagliaferri L, Trakatelli M, Vieira R, Zalaudek I, Garbe C; EADO"A, EDF"B, ESTRO"C, UEMS"D and EADV"E. European consensus-based interdisciplinary guideline for diagnosis and treatment of basal cell carcinoma-update 2023. Eur J Cancer. 2023 Oct;192:113254. doi: 10.1016/j.ejca.2023.113254. Epub 2023 Jul 28.

    PubMed 37604067

  • Skin Cancer Foundation. Skin Cancer Information [Internet]. [cited 2025 Nov 19]. Available from: https://www.skincancer.org/skin-cancer-information/

  • Soegaard S, Aarup V, Serup J, Bove T, Zawada T, Jessen A, Poli M. High-frequency (20 MHz) high-intensity focused ultrasound system for dermal intervention: A 12-week local tolerance study in minipigs. Skin Res Technol. 2020 Mar;26(2):241-254. doi: 10.1111/srt.12786. Epub 2019 Sep 20.

    PubMed 31541524

  • Bove T, Zawada T, Serup J, Jessen A, Poli M. High-frequency (20-MHz) high-intensity focused ultrasound (HIFU) system for dermal intervention: Preclinical evaluation in skin equivalents. Skin Res Technol. 2019 Mar;25(2):217-228. doi: 10.1111/srt.12661. Epub 2019 Jan 8.

    PubMed 30620418

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Focused Ultrasound and Cryotherapy in people with Superficial Basal Cell Carcinoma and Nodular Basal Cell Carcinoma, run by Jussi Salonen at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Investigator (+358401986550, jussi.salonen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment efficacy (time frame: From treatment to the end of follow up at 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07384078, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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