Surgical excision versus combined therapy with Curettage and Imiquimod for Nodular Basal Cell Carcinoma: an open, non-inferiority, randomized controlled trial
- Conditions
- Nodular Basal Cell CarcinomaSkincancer10040900
- Registration Number
- NL-OMON44993
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 144
- Adults aged 18 years or older
- Primary histologically proven nodular basal cell carcinoma * 4mm and * 20mm in diameter
- Patient is able to apply cream
- Comorbidities may not interfere with study treatment (evaluated by investigator)
- Capable to understand instructions
- A nodular BCC located in the H-zone of the face or hairy scalp
- Recurrent (previously treated) nBCC
- Aggressive histopathologcial BCC subtypes
- Life expectancy of less than five years
- Breast-feeding or pregnant women
- Serious comorbidities (evaluated by investigator)
- Use of immunosuppressive medication during the trial period untill 3 months after end of treatment or within 30 days before enrolment
- Patients with genetic skin cancer disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study endpoint is the proportion free of initial nBCC patients at<br /><br>one 1 year after end of treatment (defined as absence of initial treatment<br /><br>failure or any clinical signs of subsequent local recurrence). In case there is<br /><br>clinical suspicion of BCC, a 3 mm punch biopsy will be taken for histological<br /><br>verification.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome parameters are the 5-year cumulative probability of<br /><br>recurrence free of initial nBCC survival at 5 years after end of treatment,<br /><br>compliance, cosmetic appearance, patient satisfaction, patient preference and<br /><br>cost-effectiveness. </p><br>