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Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis

RecruitingPhase 4Ages 18 Years - anyAllMaastricht University Medical Center
NCT06499415 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

5-Fluorouracil (5FU) is proven to be the most effective therapy in field directed treatment for AK, with Jansen et al. reporting a 1-year probability of treatment success of 74.7%. However, treatment with 5FU is associated with side effects, like erythema, itching, a burning sensation and crusting, and a burdensome dosing regimen of twice daily application for four weeks. This long treatment duration in combination with side-effects and overall lifestyle adjustments during treatment can be the reason for poor adherence and premature termination, and it can also lead to future refusal of 5FU therapy. Therefore, room for improvement lies in increasing the tolerability, in terms of side effects or treatment duration, while maintaining the efficacy of 5FU in the treatment of AK. Addition therapy, which can shorten the duration of treatment, might be the key to success. Calcipotriol (CAL) en

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults above 18 years of age * Clinical and dermoscopical diagnosis of AK by a dermatologist, in one or more area(s): * Face, ears, (balding) scalp * Neck/Shawl area, including the sun-exposed chest area * Upper extremities * Number of AK lesions ≥4 in a continuous treatment area of up to 100 cm2 * AK Olsen grade I-III Exclusion Criteria: * Previous field treatment for AK within 2cm of the treatment area, within 3 months * (non) melanoma skin cancer in treatment area * Mucosal lesions * Genetic skin cancer disorder * Women who are pregnant or breastfeeding * Women of childbearing potential, who are not willing to use effective contraceptive measures * Previous allergy or intolerance to either 5FU or calcipotriol * Patients with known contra-indications for calcipotriol use: previous diagnosis of hyper-calcemia, disturbed calcium metabolism, severe kidney or liver dysfunction * Concurrent use of oral capecitabine or any other topical or systemic chemopreventive agent for any indication * Concurrent use of other topical treatments registered as treatment for AK * Limited understanding of the Dutch language and not being able to give informed consent (incapacitated patients)
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What it tests

  • 5FU-Calcipotriol
  • 5-FU 50 MG/ML Topical Cream
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Where

4 sites
Zuyderland Medical Center
Heerlen, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
VieCuri Medical Center
Venlo, Netherlands
Catharina Hospital Eindhoven
Eindhoven, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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