NCT06499415 Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
| NCT ID | NCT06499415 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Maastricht University Medical Center |
| Condition | Actinic Keratoses |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2024-09-04 |
| Primary Completion | 2029-03-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 232 participants in total. It began in 2024-09-04 with a primary completion date of 2029-03-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 combination therapy with 5FU-CAL is non-inferior to a full course of 5FU monotherapy with respect to the 1-year probability of treatment success.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06499415 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Actinic Keratoses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06499415 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06499415 currently recruiting?
Yes, NCT06499415 is actively recruiting participants. Contact the research team at myrthe.moermans@mumc.nl for enrollment information.
Where is the NCT06499415 trial being conducted?
This trial is being conducted at Heerlen, Netherlands, Maastricht, Netherlands, Venlo, Netherlands, Eindhoven, Netherlands.
Who is sponsoring the NCT06499415 clinical trial?
NCT06499415 is sponsored by Maastricht University Medical Center. The trial plans to enroll 232 participants.