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Not yet recruiting NCT07384078

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

No phase Interventional Superficial Basal Cell Carcinoma Nodular Basal Cell Carcinoma Bowen's Disease BCC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High Intensity Focused Ultrasound, Cryotherapy.
Who it may be relevant to
Registry conditions: Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma, Bowen's Disease, BCC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

  • Device High Intensity Focused Ultrasound
    High intensity focused ultrasound
  • Procedure Cryotherapy
    Liquid nitrogen cryotherapy

Primary outcome measures

  • Treatment efficacy [Time frame: From treatment to the end of follow up at 5 years]
Secondary outcome measures (9)
  • Pain during treatment assessed by NRS [Time frame: 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]
  • Post treatment reactions assessed by both observer and patient [Time frame: 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]
  • Healing time assessed by patient. How many weeks ago? [Time frame: 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]
  • Patient satisfaction inquiry, modified 6 questions [Time frame: 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]
  • Other adverse events related to the given treatment [Time frame: From treatment visit to the end of follow up at 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Finland · 1 center
  • HUS Iho- ja allergiasairaala — Helsinki

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-Seg PMID 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. PMID 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. PMID 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. PMID 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. PMID 18593385

Identifiers

NCT: NCT07384078 · HUS/6520/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗