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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)
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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)
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Secondary ID [1]
311996
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
CICAFU
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Skin Cancer
333642
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Condition category
Condition code
Cancer
330328
330328
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0
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Non melanoma skin cancer
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328483
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Treatment: Other
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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.)
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Control group
Active
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Outcomes
Primary outcome [1]
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Number of Topical 5% Fluorouracil (Efudix) applications
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Assessment method [1]
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Percentage of patients achieving a minimum of 42 applications of Topical 5% Fluorouracil (Efudix) through patient self-reported online surveys.
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Timepoint [1]
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Weekly over 4-week treatment period.
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Primary outcome [2]
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Worst local skin reaction score
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Assessment method [2]
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Local skin reaction grading scale (Rosen et al, Dermatol ther 2014) during the treatment with Topical 5% Fluorouracil (Efudix)
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Timepoint [2]
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Weekly over 4-week treatment period.
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Secondary outcome [1]
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Side effect severity score
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Assessment method [1]
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Local skin reaction grading scale (Rosen et al, Dermatol ther 2014)
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Timepoint [1]
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Weekly over 4-week treatment period.
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Secondary outcome [2]
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Change in the number of AKs
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Assessment method [2]
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Data will be collected by assessments by the clinicians during follow-up visits as well as long term outcomes ((number of AKs) that will be collected at 12-months via passive follow-up.
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Timepoint [2]
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At 4 weeks and 12 months post-treatment commencement.
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Secondary outcome [3]
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Itch score
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Assessment method [3]
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Dermatology Quality of Life Index scoring via self-reported surveys.
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Timepoint [3]
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At Week 2 and Week 4 of treatment period.
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Secondary outcome [4]
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Quality of Life (QOL)
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Assessment method [4]
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Dermatology Quality of Life Index scoring
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Timepoint [4]
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At 2 weeks and 4 weeks over treatment period
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Secondary outcome [5]
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Number of interruptions
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Assessment method [5]
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Number of interruptions within 4 weeks with use of topical steroids via self-reported surveys.
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Timepoint [5]
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Weekly for 4 weeks over treatment period
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Secondary outcome [6]
434443
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Pain Score
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Assessment method [6]
434443
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Pain score at 1,2,3 and 4 weeks (phone or online survey). Subgroup analysis will be also performed based on stratification criteria.
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Timepoint [6]
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Weekly over 4-week period over treatment period.
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Secondary outcome [7]
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Total number of fluorouracil applications
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Assessment method [7]
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log by patient via online REDCap survey
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Timepoint [7]
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Daily reporting for 4 weeks over treatment period
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Secondary outcome [8]
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Weight of fluorouracil
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Assessment method [8]
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weight of fluorouracil applied on week 2, 3 and 4 as compared to week 1 as measured by clinicians at follow-up visits.
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Timepoint [8]
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At week 2, 3 and 4 over treatment period.
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Secondary outcome [9]
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Achieving minimum of 28 applications.
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Assessment method [9]
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Percentage of patients achieving a minimum of 28 applications based on daily self reporting over the treatment period.
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Timepoint [9]
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Number of applications over 4-week period assessed at the end of 4-week treatment period.
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Secondary outcome [10]
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Achieving the maximum of 56 applications.
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Assessment method [10]
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Percentage of patients achieving maximum of 56 applications based on daily self reporting over the treatment period.
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Timepoint [10]
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Number of applications over 4-week period assessed at the end of 4-week treatment period.
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Secondary outcome [11]
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Basal Cell Carcinoma (BCC) occurrence
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Assessment method [11]
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BCC occurrence and numbers at 12 months collected via passive follow-up in medical records.
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Timepoint [11]
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At 12 months post treatment commencement.
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Secondary outcome [12]
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Patient experience
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Assessment method [12]
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If treated previously with 5-FU, evaluate patient experience with Cicaplast Baume B5+ via patient reported outcomes in follow-up surveys.
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Timepoint [12]
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Weekly for 4 weeks over treatment period
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Secondary outcome [13]
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Squamous Cell Carcinoma (SCC) occurrence
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Assessment method [13]
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SCC occurrence and numbers at 12 months collected via passive follow-up in medical records.
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Timepoint [13]
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At 12 months post treatment commencement.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
26475
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
42461
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
316342
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University
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Name [1]
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The University of Queensland
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Address [1]
316342
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Country [1]
316342
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Australia
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Funding source category [2]
316819
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Other
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Name [2]
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La Roche Posay
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Address [2]
316819
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Country [2]
316819
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Australia
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Primary sponsor type
University
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Name
The University of Queensland
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Address
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Country
Australia
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Secondary sponsor category [1]
319048
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None
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Name [1]
319048
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Address [1]
319048
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Country [1]
319048
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315153
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Metro South Human Research Ethics Committee
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Ethics committee address [1]
315153
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https://metrosouth.health.qld.gov.au/research/about-us/hrec
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Ethics committee country [1]
315153
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Australia
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Date submitted for ethics approval [1]
315153
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02/04/2024
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Approval date [1]
315153
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11/04/2024
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Ethics approval number [1]
315153
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Kiarash Khosrotehrani
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Address
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The University of Queensland Frazer Institute, Level 6, Translational Research Institute, 37 Kent Street WOOLLOONGABBA QLD 4102
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Country
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Australia
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Phone
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+61 7 3443 7088
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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CICAFU Trials Coordinator
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Address
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The University of Queensland Frazer Institute, Level 6, Translational Research Institute, 37 Kent Street WOOLLOONGABBA QLD 4102
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Country
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Australia
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Phone
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+61 7 3443 7088
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Kiarash Khosrotehrani
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Address
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The University of Queensland Frazer Institute, Level 6, Translational Research Institute, 37 Kent Street WOOLLOONGABBA QLD 4102
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Country
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Australia
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Phone
133840
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+61 7 3443 7088
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Fax
133840
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Email
133840
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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