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Combination therapy of 5-Fluorouracil and Calcipotriol versus 5-Fluorouracil in the treatment of Actinic Keratosis: a multicentre randomized controlled clinical trial
EU CTIS ID: 2024-511409-42-00
What this study is testing
The primary objective is to evaluate whether four or six day treatment with 5-Fluorouracil combined with calcipotriol is non-inferior to four weeks of 5-Fluorouracil monotherapy in terms of the 1-year probability of treatment success in patients with actinic keratosis. Treatment success is defined as ≥75% reduction in the number of AK lesions in the treatment area.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 OR Neck/Shawl area, including the sun-exposed chest area OR Upper extremities
- Number of AK lesions ≥4 in a continuous treatment area of up to 100 cm2
- AK Olsen grade I-III
You likely can't join if
- 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
- Previous allergy or intolerance to either 5Fluorouracil or calcipotriol
See the full eligibility 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 OR Neck/Shawl area, including the sun-exposed chest area OR Upper extremities
- Number of AK lesions ≥4 in a continuous treatment area of up to 100 cm2
- AK Olsen grade I-III
- 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
- Previous allergy or intolerance to either 5Fluorouracil 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
- Limited understanding of the Dutch language and not being able to give informed consent
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.