Efficacy of Topical 5-Fluorouracil Vs Calcipotriol As Photodynamic Therapy Pre-treatment for Field Actinic Keratoses

The purpose of this study is to compare two different creams (5-fluorouracil, known as Efudix, and calcipotriol, known as Dovonex) to see which one works better when used before Photodynamic Therapy (PDT) to treat sun-damaged skin on the scalp (called actinic keratoses). PDT is often used on its own to treat these spots, but it doesn't always remove them completely. Using Efudix or Dovonex before PDT might improve the results, but we don't yet know which is better. The main questions are - 1. Is efudix or dovonex better at treating actinic keratoses when used prior to PDT 2. Is efudix or dovonex more tolerable for patients? Participants will be randomised to treat their scalp with efudix or dovonex for seven days prior to their first PDT treatment. They will be reviewed on day 7, prior to starting PDT, and again a week later when they present for their second PDT treatment. During follow up, patients will be reviewed at 28 days, 3, 6, 9, and 12 months after treatment. At each of these visits, the number of actinic keratoses will be counted, graded, mapped and photographed to allow assessment of improvement before and after treatment.

NCT Number	NCT06685588
Lead Sponsor	St Vincent's University Hospital, Ireland
Conditions	Actinic Keratosis of Face and Scalp, Actinic Keratoses
Enrollment	50 participants
Start Date	2025-01
Primary Completion	2026-01 (estimated)
Study Completion	2026-01 (estimated)
Updated on ClinicalTrials.gov	2024-11-12