Fluorouracil for Actinic keratosis

Inclusion criteria

• {"criterion_text":"- Adults above 18 years of age\n- Clinical and dermoscopical diagnosis of AK by a dermatologist, in one or more area(s): Face, ears, (balding) scalp OR Neck/Shawl area, including the sun-exposed chest area OR Upper extremities\n- Number of AK lesions ≥4 in a continuous treatment area of up to 100 cm2\n- AK Olsen grade I-III"}

Exclusion criteria

• {"criterion_text":"- Previous field treatment for AK within 2cm of the treatment area, within 3 months\n- (non) melanoma skin cancer in treatment area\n- Mucosal lesions\n- Genetic skin cancer disorder\n- Women who are pregnant or breastfeeding\n- Previous allergy or intolerance to either 5Fluorouracil or calcipotriol\n- Patients with known contra-indications for calcipotriol use: previous diagnosis of hyper-calcemia, disturbed calcium metabolism, severe kidney or liver dysfunction\n- Concurrent use of oral capecitabine or any other topical or systemic chemopreventive agent for any indication\n- Limited understanding of the Dutch language and not being able to give informed consent"}

Primary endpoints

• {"endpoint_text":"- The main trial endpoint is the proportion of patients achieving treatment success at 12 months post-treatment. Treatment success is defined as ≥75% reduction in the number of AK lesions in the treatment area (partial clearance).","definition_or_measurement_approach":"Treatment success defined as ≥75% reduction in the number of AK lesions in the treatment area; measured as the proportion of patients achieving this at 12 months post-treatment."}

Secondary endpoints

• {"endpoint_text":"- The proportion of patients achieving treatment success at 3 months post-treatment. Treatment success is defined as ≥75% reduction in the number of AK lesions in the treatment area (partial clearance).","definition_or_measurement_approach":"Treatment success defined as ≥75% reduction in number of AK lesions; measured as proportion at 3 months post-treatment."}
• {"endpoint_text":"- The proportion of patients achieving 100% clearance of AK lesions (complete clearance) at 3 and 12 months post-treatment.","definition_or_measurement_approach":"Complete clearance defined as 100% reduction in AK lesions; measured as proportion at 3 and 12 months post-treatment."}
• {"endpoint_text":"- The mean percentage change in AK lesions compared to baseline, measured at 3 and 12 months post-treatment","definition_or_measurement_approach":"Mean percent change from baseline in number of AK lesions at 3 and 12 months."}
• {"endpoint_text":"- The mean change in Actinic Keratosis Area and Severity Index (AKASI) score compared to baseline, measured at 3 and 12 months post-treatment","definition_or_measurement_approach":"Mean change from baseline in AKASI score at 3 and 12 months."}
• {"endpoint_text":"- Recurrence rate, defined as the proportion of patients with new lesions at 3 and 12 months post-treatment","definition_or_measurement_approach":"Recurrence defined as presence of new lesions; measured as proportion with new lesions at 3 and 12 months."}
• {"endpoint_text":"- The proportion of patients who need retreatment within 12 months after finishing treatment","definition_or_measurement_approach":"Measured as proportion of patients requiring retreatment within 12 months after finishing treatment."}
• {"endpoint_text":"- The proportion of patients experiencing moderate to severe adverse effects, as reported by the patients in their treatment diary and at 3 months post-treatment.","definition_or_measurement_approach":"Measured as proportion reporting moderate to severe adverse effects in treatment diary and at 3 months post-treatment."}
• {"endpoint_text":"- Patient satisfaction with treatment at 3 and 12 months post-treatment, expressed as the proportion of patients who indicate to be satisfied with their treatment.","definition_or_measurement_approach":"Measured as proportion of patients indicating satisfaction at 3 and 12 months post-treatment."}
• {"endpoint_text":"- Mean score for quality of life on the Skindex-17 questionnaire at baseline, 1 week after finishing treatment and 3 and 12 months post-treatment.","definition_or_measurement_approach":"Mean Skindex-17 QoL score measured at baseline, 1 week after finishing treatment, and at 3 and 12 months."}
• {"endpoint_text":"- Treatment adherence expressed as proportion of patients with complete adherence to the prescribed treatment regimen.","definition_or_measurement_approach":"Measured as proportion of patients with complete adherence to prescribed regimen (treatment diary and adherence assessments)."}
• {"endpoint_text":"- Exploratory endpoint: the long-term probability of cSCC development, expressed as the 3-year cumulative probability of cSCC development.","definition_or_measurement_approach":"Expressed as 3-year cumulative probability of developing cutaneous squamous cell carcinoma (cSCC); long-term follow-up/observation."}

Other endpoints

• {"endpoint_text":"- Exploratory endpoint: the long-term probability of cSCC development, expressed as the 3-year cumulative probability of cSCC development.","definition_or_measurement_approach":"Expressed as 3-year cumulative probability of cSCC development (exploratory long-term outcome)."}

Netherlands

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

648

Number Of Sites

4

Number Of Participants

232

Primary sponsor

Full Name

University Hospital Maastricht

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands