CICAPLAST Baume B5+: tolerability and observance of Topical 5% Fluorouracil in Patients diagnosed with Actinic Keratoses (AK)

Phase 3

• Conditions: Skin Cancer; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12624000911594
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-26
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Adult patients (18 years old and older)
2. Prescribed a field therapy with Topical 5% Fluorouracil for actinic keratoses or in chemoprevention of SCC on the face or hands and/or arms
3. Able to give informed consent.

Exclusion Criteria

- Patients with hypersensitivity to 5-FU, defined as inability to tolerate topical fluorouracil prompting severe reaction within 3 days of starting.
- Patients applying routinely other topical agents to the face and/or arms with the exception of sunscreen
- Patients with intellectual or mental impairment who are unable to provide informed consent.
- Patients who are pregnant / planning pregnancy
- Patients with known dihydropyrimidine dehydrogenase enzyme deficiency
- Patients unable to use a smartphone, unable to receive text messages and emails, unable to attend the face-to-face visits.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of Topical 5% Fluorouracil (Efudix) applications[Percentage of patients achieving a minimum of 42 applications of Topical 5% Fluorouracil (Efudix) through patient self-reported online surveys. Weekly over 4-week treatment period.];Worst local skin reaction score[Local skin reaction grading scale (Rosen et al, Dermatol ther 2014) during the treatment with Topical 5% Fluorouracil (Efudix) Weekly over 4-week treatment period.]