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

NCT06685588 | Not Yet Recruiting

• 1 other identifier: RS24-046
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Is efudix or dovonex better at treating actinic keratoses when used prior to PDT
2. 2.Is efudix or dovonex more tolerable for patients?

Conditions

Actinic Keratosis of Face and Scalp; Actinic Keratoses

Keywords

efudix; dovonex; 5-fluorouracil; calcipotriol; actinic keratosis; actinic keratoses

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

Calcipotriol / Dovonex

ACTIVE COMPARATOR

Randomised to PDT pre-treatment with calcipotriol

Drug: 5-FU (fluorouracil); Drug: Calcipotriol

Calcipotriol /Dovonex

ACTIVE COMPARATOR

Calcipotriol pre-treatment prior to PDT

Drug: 5-FU (fluorouracil); Drug: Calcipotriol

Interventions

5-FU (fluorouracil) DRUG

Topical 5-FU (fluorouracil) pretreatment prior to dovonex

Also known as: Efudix

Calcipotriol / Dovonex; Calcipotriol /Dovonex

Calcipotriol DRUG

Calcipotriol pre-treatment prior to PDT

Calcipotriol / Dovonex; Calcipotriol /Dovonex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18 years old)
• Field actinic keratoses on scalp
• Generally good health

You may not qualify if:

• Immunosuppression
• Unable to provide consent
• Abnormal photosensitivity
• Contact allergy to metvix / 5-FU / calcipotriol / topical corticosteroids
• Pregnancy or breastfeeding

Sponsors & Collaborators

• St Vincent's University Hospital, Ireland: lead

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Fluorouracil; calcipotriene

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Maeve Herlihy

CONTACT

012213297; maeveherlihy@svhg.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Maeve Herlihy

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share