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Combination Therapy of 5-Fluorouracil and Calcipotriol Versus 5-Fluorouracil in Treating Actinic Keratosis: A Multicentre Randomized Controlled Trial
Led by Maastricht University Medical Center · Updated on 2025-05-11
232
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for actinic keratoses (AK), a skin condition that can benefit from field-directed therapy. This study compares a new combination treatment of 5-fluorouracil (5FU) and calcipotriol (CAL) against the standard 5FU therapy alone. The goal is to find out if a shorter treatment with 5FU-CAL can be as effective as the longer 5FU-only course, while reducing side effects like redness, itching, burning, and crusting that often lead to poor adherence and early treatment stopping. The study involves two treatment groups. One group will apply a combination of topical 5FU and CAL twice daily for 4 or 6 consecutive days, depending on the treatment location. The other group will use topical 5FU alone twice daily for 4 weeks. Treatment areas include the face, ears, scalp, neck, chest, and upper extremities. The study will carefully monitor how these treatments perform over time. Participants will be followed for 12 months after finishing treatment to assess treatment success. Researchers will measure clearance and recurrence of AK lesions, side effects, patient satisfaction, treatment compliance, and quality of life at multiple points before, during, and after treatment. This thorough follow-up aims to understand how well the shorter combination therapy works compared to the standard 4-week 5FU treatment.
CONDITIONS
Brief Title
Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults above 18 years of age
- Clinical and dermoscopical diagnosis of actinic keratosis by a dermatologist in one or more areas: face, ears, balding scalp, neck/shawl area including sun-exposed chest, or upper extremities
- At least 4 actinic keratosis lesions in a continuous treatment area up to 100 cm2
- Actinic keratosis lesions graded Olsen I to III
You will not qualify if you...
- Previous field treatment for actinic keratosis within 2 cm of the treatment area in the last 3 months
- Presence of melanoma or non-melanoma skin cancer in the treatment area
- Mucosal lesions
- Genetic skin cancer disorders
- Pregnant or breastfeeding women
- Women of childbearing potential not willing to use effective contraception
- Known allergy or intolerance to 5-fluorouracil or calcipotriol
- Contraindications for calcipotriol use such as hypercalcemia, disturbed calcium metabolism, severe kidney or liver dysfunction
- Concurrent use of oral capecitabine or other topical/systemic chemopreventive agents
- Use of other topical treatments registered for actinic keratosis
- Limited understanding of Dutch language or inability to give informed consent (incapacitated patients)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days to 6 days or 4 weeks depending on treatment arm
Participants receive topical treatment with either 5FU-Calcipotriol twice daily for 4 or 6 consecutive days depending on the treatment location, or 5-FU topical cream twice daily for 4 weeks.
1 baseline visit and multiple visits during treatment as needed
Duration - 12 months after finishing treatment
Participants are monitored for treatment success, clearance, recurrence, adverse effects, patient satisfaction, and quality of life up to 12 months after finishing treatment.
Visits at 1 week, 3 months, and 12 months post-treatment
Trial Site Locations
Total: 4 locations
1
Zuyderland Medical Center
Heerlen, Limburg, Netherlands, 6419 HC
Actively Recruiting
2
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
Actively Recruiting
3
VieCuri Medical Center
Venlo, Limburg, Netherlands, 5912 BL
Actively Recruiting
4
Catharina Hospital Eindhoven
Eindhoven, North Brabant, Netherlands, 5623 EJ
Actively Recruiting
Research Team
M
Myrthe MG Moermans, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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