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.

Sex

All

Minimum age

18 Years

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

• BACKGROUNDThe Finnish Cancer Registry; Syöpätilastosovellus. Vuosiraportti 2023. [Internet]. [cited 2025 Nov 19]. Available from: https://syoparekisteri.fi/tilastot/tautitilastot/
• BACKGROUNDSchlessinger 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
• BACKGROUNDHansen 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
• BACKGROUNDWang 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
• BACKGROUNDBasset-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.