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Trial registered on ANZCTR


Registration number
ACTRN12624000911594
Ethics application status
Approved
Date submitted
26/06/2024
Date registered
26/07/2024
Date last updated
26/07/2024
Date data sharing statement initially provided
26/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
CICAPLAST Baume B5+: tolerability and observance of Topical 5% Fluorouracil in Patients diagnosed with Actinic Keratoses (AK)
Scientific title
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)
Secondary ID [1] 311996 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CICAFU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer 333642 0
Condition category
Condition code
Cancer 330328 330328 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328483 0
Treatment: Other
Comparator / control treatment
Comparator is standard of care of receiving Topical 5% Fluorouracil as prescribed, 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 and according to (Ref: JAMA Dermatol. 2018 Feb 1;154(2):167-174.)
Control group
Active

Outcomes
Primary outcome [1] 338086 0
Number of Topical 5% Fluorouracil (Efudix) applications
Timepoint [1] 338086 0
Weekly over 4-week treatment period.
Primary outcome [2] 338087 0
Worst local skin reaction score
Timepoint [2] 338087 0
Weekly over 4-week treatment period.
Secondary outcome [1] 434437 0
Side effect severity score
Timepoint [1] 434437 0
Weekly over 4-week treatment period.
Secondary outcome [2] 434438 0
Change in the number of AKs
Timepoint [2] 434438 0
At 4 weeks and 12 months post-treatment commencement.
Secondary outcome [3] 434439 0
Itch score
Timepoint [3] 434439 0
At Week 2 and Week 4 of treatment period.
Secondary outcome [4] 434441 0
Quality of Life (QOL)
Timepoint [4] 434441 0
At 2 weeks and 4 weeks over treatment period
Secondary outcome [5] 434442 0
Number of interruptions
Timepoint [5] 434442 0
Weekly for 4 weeks over treatment period
Secondary outcome [6] 434443 0
Pain Score
Timepoint [6] 434443 0
Weekly over 4-week period over treatment period.
Secondary outcome [7] 434444 0
Total number of fluorouracil applications
Timepoint [7] 434444 0
Daily reporting for 4 weeks over treatment period
Secondary outcome [8] 434445 0
Weight of fluorouracil
Timepoint [8] 434445 0
At week 2, 3 and 4 over treatment period.
Secondary outcome [9] 434448 0
Achieving minimum of 28 applications.
Timepoint [9] 434448 0
Number of applications over 4-week period assessed at the end of 4-week treatment period.
Secondary outcome [10] 434465 0
Achieving the maximum of 56 applications.
Timepoint [10] 434465 0
Number of applications over 4-week period assessed at the end of 4-week treatment period.
Secondary outcome [11] 434466 0
Basal Cell Carcinoma (BCC) occurrence
Timepoint [11] 434466 0
At 12 months post treatment commencement.
Secondary outcome [12] 434467 0
Patient experience
Timepoint [12] 434467 0
Weekly for 4 weeks over treatment period
Secondary outcome [13] 437716 0
Squamous Cell Carcinoma (SCC) occurrence
Timepoint [13] 437716 0
At 12 months post treatment commencement.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed as only site pharmacy is aware of random allocation and not participating in the study evaluation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26475 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 42461 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 316342 0
University
Name [1] 316342 0
The University of Queensland
Country [1] 316342 0
Australia
Funding source category [2] 316819 0
Other
Name [2] 316819 0
La Roche Posay
Country [2] 316819 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 319048 0
None
Name [1] 319048 0
Address [1] 319048 0
Country [1] 319048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315153 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 315153 0
https://metrosouth.health.qld.gov.au/research/about-us/hrec
Ethics committee country [1] 315153 0
Australia
Date submitted for ethics approval [1] 315153 0
02/04/2024
Approval date [1] 315153 0
11/04/2024
Ethics approval number [1] 315153 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133838 0
Prof Kiarash Khosrotehrani
Address 133838 0
The University of Queensland Frazer Institute, Level 6, Translational Research Institute, 37 Kent Street WOOLLOONGABBA QLD 4102
Country 133838 0
Australia
Phone 133838 0
+61 7 3443 7088
Fax 133838 0
Email 133838 0
[email protected]
Contact person for public queries
Name 133839 0
CICAFU Trials Coordinator
Address 133839 0
The University of Queensland Frazer Institute, Level 6, Translational Research Institute, 37 Kent Street WOOLLOONGABBA QLD 4102
Country 133839 0
Australia
Phone 133839 0
+61 7 3443 7088
Fax 133839 0
Email 133839 0
[email protected]
Contact person for scientific queries
Name 133840 0
Kiarash Khosrotehrani
Address 133840 0
The University of Queensland Frazer Institute, Level 6, Translational Research Institute, 37 Kent Street WOOLLOONGABBA QLD 4102
Country 133840 0
Australia
Phone 133840 0
+61 7 3443 7088
Fax 133840 0
Email 133840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.