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

NCT06685588 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-11-12

No results posted yet for this study

Summary

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.

Conditions

  • Actinic Keratosis of Face and Scalp
  • Actinic Keratoses

Interventions

DRUG

5-FU (fluorouracil)

Topical 5-FU (fluorouracil) pretreatment prior to dovonex

DRUG

Calcipotriol

Calcipotriol pre-treatment prior to PDT

Sponsors & Collaborators

  • St Vincent's University Hospital, Ireland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-01-31
Completion
2026-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06685588 on ClinicalTrials.gov