Combination therapy of 5-Fluorouracil and Calcipotriol versus 5-Fluorouracil in the treatment of Actinic Keratosis: a multicentre randomized controlled clinical trial

Phase 1

• Conditions: Actinic Keratosis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2024-511409-42-00
• Lead Sponsor: niversity Hospital Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-13
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 232

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 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

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, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To compare the clearance rate in both treatment groups, To compare the recurrence rate in both groups, To compare adverse effects, To compare treatment compliance, To compare the patient satisfaction, To compare the quality of life, To investigate the long-term risk of cSCC development (exploratory objective);Primary end point(s): The main trial endpoint is the proportion of patients achieving treatment success at 12 months post-treatment. Treatment success is defined as =75% reduction in the number of AK lesions in the treatment area (partial clearance).