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.
Adult (>18 years old)
Field actinic keratoses on scalp
Generally good health
Immunosuppression
Unable to provide consent
Abnormal photosensitivity
Contact allergy to metvix / 5-FU / calcipotriol / topical corticosteroids
Parallel
5-FU (fluorouracil)
DrugTopical 5-FU (fluorouracil) pretreatment prior to dovonex
Calcipotriol
DrugCalcipotriol pre-treatment prior to PDT
Efficacy of treatment as assessed by proportion of participants with complete clearance of AKs from baseline (100% reduction)
Assessed by number of participants with complete clearance of AKs at 6 months post treatment. Complete clearance is is defined as 100% reduction in the number of AKs from baseline. AKs will be counted, marked, mapped and photographed at each visit.
Tolerability of treatment
assessed by pain scores (visual analogue scale, 0-10), documentation of local effects such as erythema and erosions and recording of any adverse events
Near-complete response
number of participants with ≥ 75% reduction in number of AK lesions
Partial response rate
number of participants with 50-75% reduction in number of AK lesions
Treatment failure rate
number of participants treatment with \<50% reduction in number of AK lesions
Decrease in number AK from baseline per patient
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This trial is not recruiting at the moment. You can still explore other options:
