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Trial registered on ANZCTR


Registration number
ACTRN12618001961235
Ethics application status
Approved
Date submitted
14/11/2018
Date registered
4/12/2018
Date last updated
4/12/2018
Date data sharing statement initially provided
4/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of Sirolimus cream to prevent skin cancers in organ transplant recipients.
Scientific title
Trial of topical Sirolimus, an mTOR pathway inhibitor, to prevent skin cancers in solid organ transplant recipients.
Secondary ID [1] 296412 0
Nil known
Universal Trial Number (UTN)
U1111-1222-7687
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Keratinocyte cancer 310168 0
Basal cell carcinoma 310484 0
Squamous cell carcinoma 310485 0
Condition category
Condition code
Cancer 308921 308921 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sirolimus 1% in a gel mixing ethanol and carboxyvinyl polymer will be applied by the participant nightly for 12 weeks on the dorsum of one hand and wrist while the other hand and wrist receives the vehicle (placebo) only. The creams will be applied in a thin layer only, approximately the size of a pea.
Participants will be asked to return the tube at the end of the 12 weeks.
Intervention code [1] 312745 0
Treatment: Drugs
Comparator / control treatment
One forearm (the contralateral dorsum of the hand/wrist area) will act as a control and a placebo cream will be applied nightly by the participant.
The placebo (VERSAPRO GEL BASE) consists of Allantoin, Aloe Barbadensis Leaf Juice, Disodium EDTA, Methychloroisothiazolinone, Methylisothiazolinone, Propylene Glycol, PVM/MA Decadiene Crosspolymer, Water.
Control group
Placebo

Outcomes
Primary outcome [1] 307886 0
The composite primary outcome measure is the change in the surface and number of keratotic lesions at each time-point, as compared to initiation day, on photographic images.
Timepoint [1] 307886 0
Baseline, weeks 4,8,12 and 24 post commencement of topical Sirolimus/placebo.
Secondary outcome [1] 353230 0
Development of a skin cancer requiring intervention.
At the end of the 24-week treatment period all participants will have two skin biopsies, one from the treated area of each forearm. This will check for the presence of skin cancer and activity of the drug.
Serial digital photography will also aid in the detection of skin cancer.
Timepoint [1] 353230 0
Biopsies: 24-weeks post commencement of topical Sirolimus/placebo.
Digital photography: 0,2,4,8,12 and 24 weeks post commencement of topical Sirolimus/placebo.
Secondary outcome [2] 353231 0
Adverse events related to topical Sirolimus use. Previous clinical trials have generally not recorded serious side effects. Milder events included dry, inflamed or irritated skin, folliculitis and aggravated acne.
Timepoint [2] 353231 0
At the 2 and 12-week time points blood will be collected to check that Sirolimus levels are within the therapeutic drug concentration range (5-10ug/L).
At the 2 and 12-week time points blood will be collected to measure full blood count, electrolytes and other blood components that may indicate alterations of kidney and liver function.
At all visits (0,4,8,12 and 24 weeks post commencement of topical Sirolimus/placebo) participants will be reviewed for potential side effects.

Eligibility
Key inclusion criteria
Solid organ transplant patients will be considered if (1) they received their transplanted organ more than 12 months previously and (2) they have experienced at least 5 SCC/BCCs in the past 5 years and have at least 5 keratotic lesions on the dorsum (back) of each forearm at inclusion.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude patients who are receiving or have received Sirolimus orally, those who have received a topical field therapy (e.g. Efudex or Aldara) in the past 6 months or those who are medically unstable. We will also exclude patients if any cancer lesion requiring treatment, or any open wound, is detected on the areas to be treated and evaluated. In particular, the study will not exclude any other form of systemic preventive treatment such as acitretin or nicotinamide.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
All participants receive 2 tubes of cream, one is a placebo and one is Sirolimus cream.' Left hand' or 'right hand' application has been randomly allocated and the tubes are labelled accordingly.
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
To observe a 30% reduction in keratotic number/surface with a power of 80% and at a significance level of 0.05, 29 patients are required to be tested. Obviously, this study is essentially a pilot to determine feasibility, tolerability and safety as a first step towards a larger study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12321 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 24558 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 301019 0
Charities/Societies/Foundations
Name [1] 301019 0
PA Research Foundation
Address [1] 301019 0
PA Research Foundation
Centres for Health Research
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country [1] 301019 0
Australia
Primary sponsor type
University
Name
University of Queensland Diamantina Institute
Address
Level 6
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 300978 0
None
Name [1] 300978 0
Address [1] 300978 0
Country [1] 300978 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301774 0
Metro South HREC
Ethics committee address [1] 301774 0
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 301774 0
Australia
Date submitted for ethics approval [1] 301774 0
15/05/2018
Approval date [1] 301774 0
05/07/2018
Ethics approval number [1] 301774 0
HREC/18/QPAH/356
Ethics committee name [2] 301827 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 301827 0
The University of Queensland
Cumbrae-Stewart Building #72
St Lucia
Brisbane Queensland 4072
Ethics committee country [2] 301827 0
Australia
Date submitted for ethics approval [2] 301827 0
23/07/2018
Approval date [2] 301827 0
30/07/2018
Ethics approval number [2] 301827 0
2018001516

Summary
Brief summary
The purpose of this study is to determine whether a cream (Sirolimus) is both safe and effective in reducing the burden of skin cancer in transplant recipients.

Who is it for?

You may be eligible for this study if you are an adult who has received a solid organ transplant more than 12 months ago, and have been affected by many BCCs or SCCs.

Study details

All participants will apply the Sirolimus cream to one forearm and the placebo cream to the other forearm but they will not know the difference between each cream. Creams will be applied every night for 12 weeks.

Participants in this study will be followed up over 24 weeks to assess for any changes in skin lesions via photographs, skin biopsies and blood tests.

It is hoped that this research will help determine whether Sirolimus can be effective at preventing skin cancers in transplant recipients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88058 0
A/Prof Kiarash Khosrotehrani
Address 88058 0
University of Queensland Diamantina Institute
Translational Research Institute
Level 6
37 Kent Street
Woolloongabba QLD 4102
Country 88058 0
Australia
Phone 88058 0
+61 734437088
Fax 88058 0
+61 734436966
Email 88058 0
k.khosrotehrani@uq.edu.au
Contact person for public queries
Name 88059 0
A/Prof Kiarash Khosrotehrani
Address 88059 0
University of Queensland Diamantina Institute
Translational Research Institute
Level 6
37 Kent Street
Woolloongabba QLD 4102
Country 88059 0
Australia
Phone 88059 0
+61 734437088
Fax 88059 0
+61 734436966
Email 88059 0
k.khosrotehrani@uq.edu.au
Contact person for scientific queries
Name 88060 0
A/Prof Kiarash Khosrotehrani
Address 88060 0
University of Queensland Diamantina Institute
Translational Research Institute
Level 6
37 Kent Street
Woolloongabba QLD 4102
Country 88060 0
Australia
Phone 88060 0
+61 734437088
Fax 88060 0
+61 734436966
Email 88060 0
k.khosrotehrani@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will publish only grouped and de-identified data.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 250 0
Study protocol
Citation [1] 250 0
Link [1] 250 0
Email [1] 250 0
Other [1] 250 0
Type [2] 579 0
Ethical approval
Citation [2] 579 0
Link [2] 579 0
Email [2] 579 0
Other [2] 579 0
Type [3] 580 0
Informed consent form
Citation [3] 580 0
Link [3] 580 0
Email [3] 580 0
Other [3] 580 0
Summary results
No Results