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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
High Intensity Focused Ultrasound
DeviceHigh intensity focused ultrasound
Cryotherapy
Procedure/SurgeryLiquid nitrogen cryotherapy
Treatment groups
294 Participants
are divided into 3 treatment groupsGroup A: sBCCExperimental treatment 2 interventions
Group B: nBCCExperimental treatment 2 interventions
Group C: BDExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
From treatment to the end of follow up at 5 yearsSecondary outcomes
1
Pain during treatment assessed by NRS
Zero is equivalent to no pain and 10 indicates the worst possible pain
Time frame
Pain during treatment procedure on treatment visit2
Pain after treatment previous 4 weeks NRS
Zero is equivalent to no pain and 10 indicates the worst possible pain
Time frame
From treatment to the control visit at 4 weeks3
Post treatment reactions assessed by both observer and patient
Yes/no: crust, ulceration, erosion, erythema, oozing, infection
Time frame
From treatment to the control visit at 4 weeks4
Healing result assessed by both observer and patient
Healed (defined as no ulcer/crust left)? Yes/no
Time frame
From treatment to the control visit at 4 weeksOther outcomes
1
Treatment costs
Time and resources required on treatment, cost effectiveness analysis
Time frame
From treatment to the control at 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jussi Salonen
Lead sponsor
Helsinki University Central Hospital
Sponsor institution
HUS Skin and Allergy Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: