Safety of topical 5-FU cream in patients carrying a clinically relevant DPYD variant – The DPYDIX study
- Conditions
- <p>Actinic keratosis, morbus Bowen or superficial basal cell carcinoma</p>10040900
- Registration Number
- NL-OMON20542
- Lead Sponsor
- Stichting de Merel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 550
In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age = 18 years - Able to understand the written information and able to give informed consent - Planned treatment with topical 5-FU cream (Efudix) for any indication - Possibility to take photos of the treatment area at the designated times and send them digitally
A potential subject who meets any of the following criteria will be excluded from participation in this study: - Prior treatment with fluoropyrimidines - Known allergy to (components of) 5-FU cream - Pregnancy, breast-feeding, active child wish - Concomitant use of systemic retinoids - Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient’s safety in the opinion of the treating physician
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Appearing of moderate or severe vesicles or bullae in patients treated with 5-FU cream</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Pharmacokinetics of 5-FU cream. - Appearing of erythema, swelling, erosion, crusting, scaling, itching, diarrhea and/or fatigue. - Severity of pain and burning sensation. - Time to onset of severe 5-FU cream related toxicities; appearing of vesicles/bullae, erythema, swelling, erosion, crusting, scaling, itching, diarrhea and/or fatigue. - Tumour response at 3 months.</p><br>