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

NCT07384078 | Not Yet Recruiting DMC

• 1 other identifier: HUS/6520/2025
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy

  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 Outcomes (9)

• Pain during treatment assessed by NRS

  Pain during treatment procedure on treatment visit

• Pain after treatment previous 4 weeks NRS

  From treatment to the control visit at 4 weeks

• Post treatment reactions assessed by both observer and patient

  From treatment to the control visit at 4 weeks

• Healing result assessed by both observer and patient

  From treatment to the control visit at 4 weeks

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

  From treatment to the control visit at 4 weeks

Other Outcomes (1)

• Treatment costs

  From treatment to the control at 4 weeks

Study Arms (3)

sBCC

EXPERIMENTAL

Superficial basal cell carcinoma

Device: High Intensity Focused Ultrasound; Procedure: Cryotherapy

nBCC

EXPERIMENTAL

Nodular basal cell carcinoma

Device: High Intensity Focused Ultrasound; Procedure: Cryotherapy

BD

EXPERIMENTAL

Bowen's disease

Device: High Intensity Focused Ultrasound; Procedure: Cryotherapy

Interventions

High Intensity Focused Ultrasound DEVICE

High intensity focused ultrasound

Also known as: HIFU

BD; nBCC; sBCC

Cryotherapy PROCEDURE

Liquid nitrogen cryotherapy

Also known as: CRYO

BD; nBCC; sBCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jussi Salonen: lead
• HUS Skin and Allergy Hospital: collaborator

Study Sites (1)

HUS Iho- ja allergiasairaala

Helsinki, 00250, Finland

Location

Related Publications (33)

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

  BACKGROUND

• 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.

  PMID: 35551965 BACKGROUND

• 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.

  PMID: 18363722 BACKGROUND

• 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.

  PMID: 11298545 BACKGROUND

• 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.

  PMID: 18693158 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18593385 BACKGROUND

• 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.

  PMID: 27841126 BACKGROUND

• 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.

  PMID: 29331385 BACKGROUND

• 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.

  PMID: 27160235 BACKGROUND

• 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.

  PMID: 37604067 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 31541524 BACKGROUND

• 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.

  PMID: 30620418 BACKGROUND

• Kim M, Jung NY, Park CK, Chang WS, Jung HH, Chang JW. Comparative Evaluation of Magnetic Resonance-Guided Focused Ultrasound Surgery for Essential Tremor. Stereotact Funct Neurosurg. 2017;95(4):279-286. doi: 10.1159/000478866. Epub 2017 Aug 16.

  PMID: 28810261 BACKGROUND

• Lang BH, Wu ALH. High intensity focused ultrasound (HIFU) ablation of benign thyroid nodules - a systematic review. J Ther Ultrasound. 2017 May 17;5:11. doi: 10.1186/s40349-017-0091-1. eCollection 2017.

  PMID: 28523127 BACKGROUND

• Peek MCL, Wu F. High-intensity focused ultrasound in the treatment of breast tumours. Ecancermedicalscience. 2018 Jan 10;12:794. doi: 10.3332/ecancer.2018.794. eCollection 2018.

  PMID: 29434660 BACKGROUND

• Lamsam L, Johnson E, Connolly ID, Wintermark M, Hayden Gephart M. A review of potential applications of MR-guided focused ultrasound for targeting brain tumor therapy. Neurosurg Focus. 2018 Feb;44(2):E10. doi: 10.3171/2017.11.FOCUS17620.

  PMID: 29385922 BACKGROUND

• Barile A, Arrigoni F, Zugaro L, Zappia M, Cazzato RL, Garnon J, Ramamurthy N, Brunese L, Gangi A, Masciocchi C. Minimally invasive treatments of painful bone lesions: state of the art. Med Oncol. 2017 Apr;34(4):53. doi: 10.1007/s12032-017-0909-2. Epub 2017 Feb 24.

  PMID: 28236103 BACKGROUND

• Quinn SD, Gedroyc WM. Thermal ablative treatment of uterine fibroids. Int J Hyperthermia. 2015 May;31(3):272-9. doi: 10.3109/02656736.2015.1010608. Epub 2015 Mar 27.

  PMID: 25815582 BACKGROUND

• Ellens NP, Partanen A. Preclinical MRI-Guided Focused Ultrasound: A Review of Systems and Current Practices. IEEE Trans Ultrason Ferroelectr Freq Control. 2017 Jan;64(1):291-305. doi: 10.1109/TUFFC.2016.2609238. Epub 2016 Sep 13.

  PMID: 27662675 BACKGROUND

• White E, Heishman D, Platforms Director S, Che-yi Chao J, Outreach A. Focused Ultrasound Foundation State of the Field 2025 [Internet]. [cited 2025 Nov 19]. Available from: https://cdn.fusfoundation.org/2025/07/31085318/FUSF-State-of-the-Field-2025_July-31.pdf

  BACKGROUND

• Calik J, Sauer N, Wozniak B, Wojnar A, Pietkiewicz P, Dziegiel P. Pilot Study on High-Intensity Focused Ultrasound (HIFU) for Basal Cell Carcinoma: Effectiveness and Safety. J Clin Med. 2024 Jun 1;13(11):3277. doi: 10.3390/jcm13113277.

  PMID: 38892988 BACKGROUND

• Serup J, Bove T, Zawada T, Jessen A, Poli M. High-frequency (20 MHz) high-intensity focused ultrasound: New Treatment of actinic keratosis, basal cell carcinoma, and Kaposi sarcoma. An open-label exploratory study. Skin Res Technol. 2020 Nov;26(6):824-831. doi: 10.1111/srt.12883. Epub 2020 Jun 17.

  PMID: 32557832 BACKGROUND

• Al-Jumaily AM, Liaquat H, Paul S. Focused Ultrasound for Dermal Applications. Ultrasound Med Biol. 2024 Jan;50(1):8-17. doi: 10.1016/j.ultrasmedbio.2023.09.004. Epub 2023 Oct 7.

  PMID: 37806924 BACKGROUND

• Elhelf IAS, Albahar H, Shah U, Oto A, Cressman E, Almekkawy M. High intensity focused ultrasound: The fundamentals, clinical applications and research trends. Diagn Interv Imaging. 2018 Jun;99(6):349-359. doi: 10.1016/j.diii.2018.03.001. Epub 2018 May 18.

  PMID: 29778401 BACKGROUND

• Kuijpers DI, Thissen MR, Berretty PJ, Ideler FH, Nelemans PJ, Neumann MH. Surgical excision versus curettage plus cryosurgery in the treatment of basal cell carcinoma. Dermatol Surg. 2007 May;33(5):579-87. doi: 10.1111/j.1524-4725.2007.33117.x.

  PMID: 17451581 BACKGROUND

• Park HE, Park JW, Kim YH, Han JH, Bang CH, Park YM, Lee JH. Analysis on the Effectiveness and Characteristics of Treatment Modalities for Bowen's Disease: An Observational Study. J Clin Med. 2022 May 12;11(10):2741. doi: 10.3390/jcm11102741.

  PMID: 35628868 BACKGROUND

• Morton CA, Whitehurst C, Moseley H, McColl JH, Moore JV, Mackie RM. Comparison of photodynamic therapy with cryotherapy in the treatment of Bowen's disease. Br J Dermatol. 1996 Nov;135(5):766-71.

  PMID: 8977678 BACKGROUND

• Hernberg Micaela, Mäkelä Siru, Ilmonen Suvi, Vuoristo Mikko, Juteau Susanna, Hannuksela-Svahn Anna, et al. Kansallinen ei-melanoottisten ihosyöpien hoito-ohjeistus. 2025 Dec.

  BACKGROUND

• WHO, Lucas Robyn, Prüss-Üstün Annette. Solar ultraviolet radiation : global burden of disease from solar ultraviolet radiation. World Health Organization, Public Health and the Environment; 2006.

  BACKGROUND

• Bentzen J, Kjellberg J, Thorgaard C, Engholm G, Phillip A, Storm HH. Costs of illness for melanoma and nonmelanoma skin cancer in Denmark. Eur J Cancer Prev. 2013 Nov;22(6):569-76. doi: 10.1097/CEJ.0b013e328360150c.

  PMID: 23542376 BACKGROUND

MeSH Terms

Conditions

Bowen's Disease; Carcinoma, Basal Cell

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sari Koskenmies, Head of Department

  Helsinki University Hospital, Skin and Allergy Hospital, Dermatologic procedure unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Investigator

CONTACT

+358401986550; jussi.salonen@hus.fi

Clinical Investigator

CONTACT

+358504287980; mari.salmivuori@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)