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Study identifier: NCT06499415 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Actinic Keratoses  ·  Sponsor: Maastricht University Medical Center

PhasePhase 4
Planned participants232
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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) enhances thymic stromal lymphopoietin (TSLP), an epithelium-derived cytokine, which promotes antitumor immunity. Therefore, it is known to have a synergistic effect when combined with 5FU in the treatment of AK. This suggests that short-term treatment with 5FU-CAL is effective and provides the opportunity to shorten duration of treatment, thereby improving tolerability of treatment and full adherence to the treatment regimen. However, no study compared 5FU-CAL combination therapy with standard 5FU treatment for a duration of 28 days. This study aims to evaluate whether a short course of combina…

This description comes directly from the study's public registry record.

Talk to the study team

Myrthe MG Moermans, MD  ·  0031433877295  ·  myrthe.moermans@mumc.nl

Always discuss trial participation with your own doctor first.

Locations (4)

Zuyderland Medical CenterHeerlen, Limburg, NetherlandsRecruiting
Maastricht University Medical CenterMaastricht, Limburg, NetherlandsRecruiting
VieCuri Medical CenterVenlo, Limburg, NetherlandsRecruiting
Catharina Hospital EindhovenEindhoven, North Brabant, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT06499415