Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Jul 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for Actinic Keratosis (AK), a skin condition caused by sun damage. Researchers want to see if combining two medications, 5-Fluorouracil (5FU) and Calcipotriol (CAL), is as effective as using 5FU alone, but for a shorter period. 5FU is commonly used to treat AK, but it can cause side effects like redness, itching, and a burning sensation, making it hard for some patients to stick with the treatment. By combining it with CAL, which can boost the body's immune response against skin issues, the hope is to reduce treatment time and improve comfort while still achieving good results.

To participate, you need to be an adult over 18 with at least four visible AK lesions in certain sun-exposed areas, such as the face or arms. You cannot have had other treatments for AK in the last three months or have certain skin conditions. If you join the study, you'll receive treatment for either the combined therapy or just 5FU, and you'll be monitored for a year to see how well the treatments work. This trial aims to find a more tolerable and effective option for managing Actinic Keratosis, which could make a big difference for patients dealing with this condition.

Gender

ALL

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)