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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt Vincent's University Hospital, Ireland

About this trial

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.

Eligibility criteria

Qualifiers

Adult (>18 years old)

Field actinic keratoses on scalp

Generally good health

Disqualifiers

Immunosuppression

Unable to provide consent

Abnormal photosensitivity

Contact allergy to metvix / 5-FU / calcipotriol / topical corticosteroids

Trial design

Treatments tested in this trial

  • 5-FU (fluorouracil)
  • Calcipotriol

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

This trial has no locations