Clinical trial · Interventional
Efficacy of Topical 5-Fluorouracil Vs Calcipotriol As Photodynamic Therapy Pre-treatment for Field Actinic Keratoses
Efficacy of Topical 5-FUvs Calcipotriol As PDT Pre-treatment for Field Actinic Keratoses
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
| Actinic Keratosis of Face and Scalp | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU (fluorouracil) | Drug | Fluorouracil | ALIAS |
| Calcipotriol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Calcipotriol / Dovonex
- description
- Randomised to PDT pre-treatment with calcipotriol
- interventionNames
- Drug: 5-FU (fluorouracil)
- Drug: Calcipotriol
- type
- ACTIVE_COMPARATOR
- label
- Calcipotriol /Dovonex
- description
- Calcipotriol pre-treatment prior to PDT
- interventionNames
- Drug: 5-FU (fluorouracil)
- Drug: Calcipotriol
Primary outcomes (2)
- measure
- Efficacy of treatment as assessed by proportion of participants with complete clearance of AKs from baseline (100% reduction)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult (\>18 years old) * Field actinic keratoses on scalp * Generally good health Exclusion Criteria: * Immunosuppression * Unable to provide consent * Abnormal photosensitivity * Contact allergy to metvix / 5-FU / calcipotriol / topical corticosteroids * Pregnancy or breastfeeding
References
Publications (0)
Data not yet available