Not Yet RecruitingPhase 3ACTRN12624000911594

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

CICAFU Trial: Randomised, controlled trial of CICAPLAST Baume B5+ versus standard of care on tolerability and observance of topical 5% 5-fluorouracil in Patients diagnosed with Actinic Keratoses (AK)

Sponsor

The University of Queensland

Enrollment

80 participants

Start Date

Aug 1, 2024

Study Type

Interventional

Conditions

Skin Cancer

Summary

This study aims to assess whether 5% 5-FU followed by CICAPLAST Baume B5+ on a twice daily application to the face or arms/hands will result in better tolerance and compliance as compared to 5-FU alone Who is it for? You may be eligible for this study if you are a male or female age 18 or older been prescribed a field therapy with Topical 5% Fluorouracil for actinic keratoses or in chemoprevention of SCC on the face or hands and/or arms. Study details Participants will be recruited from the Princess Alexandra hospital by treating trial physician during a clinical consultation at the dermatology clinic and followed up during weekly consultations for 4 weeks in clinic or via telehealth. They will receive either only Topical 5% Fluorouracil or Topical 5% Fluorouracil followed by Cicaplast Baume B5+ on a twice daily application to the face or hands and/or arms for 4 weeks. At the end of the study, participant's skin condition and adherence to the intervention will be assessed. It is hoped that the findings from this study will help doctors in the future treat patients being prescribed 5-FU for precancerous AK.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

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

Exclusion Criteria6

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.

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Interventions

Participants will be randomized to one of two study groups where 1) they will be receiving Topical 5% Fluorouracil or 2) they will be receiving Topical 5% Fluorouracil with Cicaplast Baume B5+ Cream.

Participants will be randomized to one of two study groups where 1) they will be receiving Topical 5% Fluorouracil or 2) they will be receiving Topical 5% Fluorouracil with Cicaplast Baume B5+ Cream. A thin layer of Fluorouracil 5% will be topically applied to the affected area/s twice a day, for 4 weeks as directed by their treating doctor. Cicaplast Baume B5+ (0.5g per 25cm squared) will be administered topically 30 mins after Topical 5% Fluorouracil application on the treatment areas as prescribed. Participants will be asked to self-report daily through online surveys if they have applied the topical cream/s to the treatment area as prescribed, report a pain score, and any side effects experienced. Participants will be evaluated weekly by the clinician for 4 weeks. Week 1 may be conducted via telehealth, and weeks 2, 3, & 4 at in-person clinic visits. Compliance in completing the daily and weekly surveys will be monitored by the project manager who will call the patient and check up on them if the surveys are not being completed.