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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJussi Salonen

About this 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?

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • High Intensity Focused Ultrasound
  • Cryotherapy

Treatment groups

294 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Jussi Salonen

Lead sponsor

Helsinki University Central Hospital

Sponsor institution

HUS Skin and Allergy Hospital

Collaborator