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Compares treatment options for Actinic Keratoses
Official title Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
ClinicalTrials.gov ID: NCT06499415
What this study is testing
What is 5FU-Calcipotriol?
5FU-Calcipotriol is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for actinic keratoses.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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%.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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
- Neck/Shawl area, including the sun-exposed chest area
- Upper extremities
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
- Women of childbearing potential, who are not willing to use effective contraceptive measures
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
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Heerlen, Limburg, Netherlands
- Maastricht, Limburg, Netherlands
- Venlo, Limburg, Netherlands
- Eindhoven, North Brabant, Netherlands
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heerlen, Limburg, Netherlands; Maastricht, Limburg, Netherlands; Venlo, Limburg, Netherlands; Eindhoven, North Brabant, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.