BCC, BD, Bowen's Disease, Nodular Basal Cell Carcinoma, Superficial Basal Cell Carcinoma
Conditions
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
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.
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
High intensity focused ultrasound
PROCEDURECryotherapy
Liquid nitrogen cryotherapy
Sponsors
Jussi Salonen
HUS Skin and Allergy Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficacy | From treatment to the end of follow up at 5 years | Histologically confirmed recurrence-free survival assessed at 1, 3 and 5 years after treatment. Recurrence during follow up: Yes/no. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain during treatment assessed by NRS | Pain during treatment procedure on treatment visit | Zero is equivalent to no pain and 10 indicates the worst possible pain |
| Pain after treatment previous 4 weeks NRS | From treatment to the control visit at 4 weeks | Zero is equivalent to no pain and 10 indicates the worst possible pain |
| Post treatment reactions assessed by both observer and patient | From treatment to the control visit at 4 weeks | Yes/no: crust, ulceration, erosion, erythema, oozing, infection |
| Healing result assessed by both observer and patient | From treatment to the control visit at 4 weeks | Healed (defined as no ulcer/crust left)? Yes/no |
| Healing time assessed by patient. How many weeks ago? | From treatment to the control visit at 4 weeks | If defined as healed by the patient. |
| Cosmetic outcome assessed by both observer and the patient | From 1 year control to the end of follow up at 5 years | Poor/fair/goof/excellent |
| Patient satisfaction inquiry, modified 6 questions | From 1 year control to the end of follow up at 5 years | Patients will be asked about an overall satisfaction with the provided treatment, recommendation of the received treatment to other patients, readiness to undergo the same treatment again and post-treatment recovery and its impact on daily life. Answers will be evaluated with a modified NRS-scale from 0 to 10 |
| Scarring after treatment POSAS 2.0 | From 1 year control to the end of follow up at 5 years | Patient and Observer Scar Assessment Scale (POSAS 2.0) |
| Other adverse events related to the given treatment | From treatment visit to the end of follow up at 5 years | Separate inquiry of adverse events |
Countries
Finland
Contacts
CONTACTClinical Investigator
PRINCIPAL_INVESTIGATORSari Koskenmies, Head of Department
Helsinki University Hospital, Skin and Allergy Hospital, Dermatologic procedure unit
Outcome results
None listed