Efficacy of Topical 5-FUvs Calcipotriol As PDT Pre-treatment for Field Actinic Keratoses
Sponsor study identifier
interventional
50
0 countries
N/A
Study Start
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 -
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 6, 2024
Actual (reported)November 12, 2024
Actual (reported)January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
6 months post treatment
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
Day of treatment, day 7 and day 28
Near-complete response
3, 6, 9 and 12 months post treatment
Partial response rate
3, 6, 9 and 12 months post treatment
Treatment failure rate
3, 6, 9 and 12 months post treatment
Decrease in number AK from baseline per patient
1, 3, 6, 9 and 12 months post final treatment.
Proportion of patients who develop a SCC in the treatment area during study follow-up period
12 months
Randomised to PDT pre-treatment with calcipotriol
Calcipotriol pre-treatment prior to PDT
Topical 5-FU (fluorouracil) pretreatment prior to dovonex
Calcipotriol pre-treatment prior to PDT
First Submitted
November 6, 2024
First Posted
November 12, 2024
Study Start
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
January 2026
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 12, 2024
Record last verified: 2024-11
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