Combining 5-Fluorouracil and Calcipotriol for treating Actinic Keratosis

Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis: a Multicentre Randomized Controlled Clinical Trial

This study is testing a new cream that combines two treatments to see if it can help adults with Actinic Keratosis feel better while reducing side effects and treatment time.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 232 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Maastricht University Medical Center (Academic / other)
• Locations: 4 sites (Heerlen, Limburg and 3 other locations)
• Trial ID: NCT06499415 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a combination therapy using 5-Fluorouracil (5FU) and Calcipotriol for the treatment of Actinic Keratosis (AK). The aim is to enhance the tolerability of treatment by potentially reducing side effects and treatment duration while maintaining the efficacy of 5FU. Participants will apply the topical cream in specified areas diagnosed with AK, and the study will assess the outcomes compared to 5FU alone. The trial is designed for adults with multiple AK lesions in sun-exposed areas.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a clinical diagnosis of Actinic Keratosis and at least four lesions in a specified treatment area.

Not a fit: Patients with a history of skin cancer in the treatment area or those with contraindications to Calcipotriol may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could improve patient adherence and outcomes in the treatment of Actinic Keratosis.

How similar studies have performed: Other studies have shown promising results with combination therapies for skin conditions, suggesting potential success for this approach.

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)

Where this trial is running

Heerlen, Limburg and 3 other locations

• Zuyderland Medical Center — Heerlen, Limburg, Netherlands (Recruiting)
• Maastricht University Medical Center — Maastricht, Limburg, Netherlands (Recruiting)
• VieCuri Medical Center — Venlo, Limburg, Netherlands (Recruiting)
• Catharina Hospital Eindhoven — Eindhoven, North Brabant, Netherlands (Recruiting)

Study contacts

• Study coordinator: Myrthe MG Moermans, MD

Conditions Actinic Keratoses; 5-Fluorouracil; Calcipotriol