Status:
RECRUITING
Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Actinic Keratoses
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 2 2029
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT06499415
Start Date
September 4 2024
End Date
March 2 2029
Last Update
May 11 2025
Active Locations (4)
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1
Zuyderland Medical Center
Heerlen, Limburg, Netherlands, 6419 HC
2
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
3
VieCuri Medical Center
Venlo, Limburg, Netherlands, 5912 BL
4
Catharina Hospital Eindhoven
Eindhoven, North Brabant, Netherlands, 5623 EJ