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Trial registered on ANZCTR


Registration number
ACTRN12621001242819
Ethics application status
Approved
Date submitted
4/08/2021
Date registered
15/09/2021
Date last updated
15/09/2021
Date data sharing statement initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study Evaluation of a Combination of Topical 5-Fluorouracil [5FU] and Calcipotriol in the Treatment of Cutaneous Actinic Keratosis [AK] and Intraepidermal Carcinoma [IEC] Lesions
Scientific title
Pilot Study Evaluation of a Combination of Topical 5-Fluorouracil [5FU] and Calcipotriol in the Treatment of Cutaneous Actinic Keratosis [AK] and Intraepidermal Carcinoma [IEC] Lesions
Secondary ID [1] 304951 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin cancer precursors 323100 0
Condition category
Condition code
Skin 320677 320677 0 0
Dermatological conditions
Skin 321007 321007 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental Treatment Cream made up of Fluorouracil 5% plus Calcipotriol 0.005% Cream

This is an open label, prospective study comparing two topical treatments for skin cancer precursors using a blinded investigator and clinical photography to determine treatment outcome.

Consenting participants will be randomised to receive either twice daily combined topical 5FU-calcipotriol cream to the left or right side of the face, and topical 5FU (EfudixTM) to the alternate side of the face. The 5FU-calcipotriol cream will be used for 4 days for AK lesions, and for 6 days for IEC lesions. The 5FU (EfudixTM) will be used on AK and IEC lesions for 2-4 weeks, as tolerated (as per current clinical practice).

The participants will be applying the creams themselves at home (as per standard of care for topical treatments of skin cancer precursors. As per standard guidelines for use of topical 5 fluorouracil, participants will be advised to apply one "pea sized" amount of cream to each cheek (left and right), forehead and chin.

To monitor adherence to treatment, patients will complete a treatment cream diary throughout the duration of treatment.

Intervention code [1] 321346 0
Treatment: Drugs
Comparator / control treatment
Standard Care for Cutaneous Actinic Keratosis [AK] and Intraepidermal Carcinoma [IEC] Lesions. This treatment involves Fluorouracil 5% [5FU Cream]. The control treatment will be applied to the opposite side of each participants' face (i.e. the side not receiving the trial intervention).
Control group
Active

Outcomes
Primary outcome [1] 328497 0
Primary outcome: patient preference for one treatment intervention over the alternative as determined by study survey. The survey will be completed at the below timepoints.
Timepoint [1] 328497 0
3 months, 1 year and 2 years post intervention completion
Secondary outcome [1] 399201 0
Secondary outcome: change in number of precancerous lesions pre and post treatment intervention (measured using baseline and repeat severity scores). Scoring has been specifically designed for the study and will be assessed by the principal investigator. Scoring will be based on number of actinic keratoses and overall level of solar damage.
Timepoint [1] 399201 0
3 months, 1 year and 2 years

Eligibility
Key inclusion criteria
Adults aged 18-85 years.
Extensive solar damage to skin over the face, as determined by a dermatologist.
Ability to comply with treatment regime as determined by the treating investigator.
Ability to undertake written informed consent prior to initiation of study protocol.
Ability/willing to attend follow up clinic visits that will include clinical photography.
Able to complete study surveys.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients commencing acitretin, other oral or topical retinoids or oral vitamin B3 in the past 3 months and for the duration of the study.
Patients with known allergy/hypersensitivity to 5FU cream.
Patients with known dihydropyrimidine dehydrogenase (DPD enzyme) deficiency.
Patients who are pregnant or breastfeeding. Female participants should avoid pregnancy and breastfeeding during use of treatment cream until three-month review.

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 will not be concealed.
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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will be conducted with statistical support via the Sunshine Coast Hospital and Health Service (SCHHS) Biostatistics & Bioinformatic Clinic. Descriptive statistics will be reported as mean and standard deviation (SD) for normally distributed continuous data, median and interquartile range (IQR) for non-normally distributed data and frequencies and percentages for categorical data. Categorical data will be compared with Chi-squared test or Fisher’s exact test where appropriate. For continuous data a Shapiro-Wilk test will performed to assess the distribution of the data. If the distribution is normal, a paired -student t-test will be performed, If not a Wilcoxon signed rank test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20133 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 34854 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 309340 0
Charities/Societies/Foundations
Name [1] 309340 0
Wishlist (Sunshine Coast Health Foundation)
Country [1] 309340 0
Australia
Primary sponsor type
Individual
Name
Dr Leith Banney
Address
Sunshine Coast University Hospital
6 Doherty Street
Birtinya QLD 4575
Country
Australia
Secondary sponsor category [1] 310306 0
Hospital
Name [1] 310306 0
Sunshine Coast University Hospital
Address [1] 310306 0
6 Doherty Street
Birtinya QLD 4575
Country [1] 310306 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309157 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 309157 0
Ethics committee country [1] 309157 0
Australia
Date submitted for ethics approval [1] 309157 0
05/07/2021
Approval date [1] 309157 0
26/07/2021
Ethics approval number [1] 309157 0

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

Contacts
Principal investigator
Name 113186 0
Dr Leith Banney
Address 113186 0
Sunshine Coast University Hospital
6 Doherty Street
Birtinya Qld 4575
Country 113186 0
Australia
Phone 113186 0
+61 7 52020000
Fax 113186 0
Email 113186 0
leith.banney@health.qld.gov.au
Contact person for public queries
Name 113187 0
Hannah Gribbin
Address 113187 0
Sunshine Coast University Hospital
6 Doherty Street
Birtinya Qld 4575
Country 113187 0
Australia
Phone 113187 0
+61 7 52020000
Fax 113187 0
Email 113187 0
hannah.gribbin@health.qld.gov.au
Contact person for scientific queries
Name 113188 0
Hannah Gribbin
Address 113188 0
Sunshine Coast University Hospital
6 Doherty Street
Birtinya Qld 4575
Country 113188 0
Australia
Phone 113188 0
+61 7 52020000
Fax 113188 0
Email 113188 0
hannah.gribbin@health.qld.gov.au

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.