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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05860881




Registration number
NCT05860881
Ethics application status
Date submitted
8/05/2023
Date registered
16/05/2023
Date last updated
10/10/2023

Titles & IDs
Public title
Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)
Scientific title
A Randomised Double-blind Placebo-controlled Trial of Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients
Secondary ID [1] 0 0
01.21 SiroSkin
Universal Trial Number (UTN)
Trial acronym
SiroSkin
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Organ Transplant Recipients 0 0
Skin Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sirolimus Topical Cream
Other interventions - Placebo

Experimental: Topical Sirolimus - Topical 1% sirolimus cream applied daily to the face for 6 months

Placebo Comparator: Placebo - Topical placebo cream applied daily to the face for 6 months


Treatment: Drugs: Sirolimus Topical Cream
The intervention topical cream consists of sirolimus 1% in a vehicle. Patients randomised to the intervention will be required to apply the sirolimus topical cream to their face for 6 months

Other interventions: Placebo
Cream containing only the base, or vehicle.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
KC development
Timepoint [1] 0 0
4 years
Secondary outcome [1] 0 0
Number of biopsy-proven SCC
Timepoint [1] 0 0
4 years
Secondary outcome [2] 0 0
Occurrence of biopsy-proven SCC
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
The number of intraepidermal carcinomas
Timepoint [3] 0 0
4 years
Secondary outcome [4] 0 0
The occurrence of intraepidermal carcinomas
Timepoint [4] 0 0
4 years
Secondary outcome [5] 0 0
Number of facial actinic keratosis
Timepoint [5] 0 0
4 years
Secondary outcome [6] 0 0
Cost-effectiveness
Timepoint [6] 0 0
4 years
Secondary outcome [7] 0 0
Intervention-related side effects
Timepoint [7] 0 0
3.5 years
Secondary outcome [8] 0 0
Number of doses
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
Completion rate
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
Intervention completion
Timepoint [10] 0 0
6 months

Eligibility
Key inclusion criteria
1. Be aged 18 years or older and able to provide consent

2. Have received an organ transplant 12 months ago or earlier

3. Have had at least 1 SCC/BCC in the past 5 years

4. Have at least 5 keratotic lesions on their face at inclusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Are currently receiving sirolimus or everolimus orally*

2. Have a skin cancer on their face requiring excisional surgery**

3. Have an open wound on their face requiring treatment

4. Are pregnant or planning to become pregnant in the next 6 months

5. Anticipate elective medical events which may prevent daily cream application.

6. Are unable to provide informed consent, complete questionnaires and attend trial site
for visits

7. Are participating in another clinical trial with an investigational drug/device aiming
to reduce skin cancers or affect level of immunosuppression

8. Planning to move overseas

(*)Patients are eligible to join the study after ceasing treatment and after a washout
period of 16 days for sirolimus and 8 days for everolimus.

(**) Once treatment of the lesion is completed these patients can be re-screened.

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)
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 receiving the treatment/s

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

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Skin Health Institute - Carlton
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
300 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melanoma and Skin Cancer Trials Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of Queensland
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
01.21 SiroSkin is a phase 3, double-blind, multi-centre, parallel-arm, randomised,
placebo-controlled trial to evaluate the use of topical 1% sirolimus in the chemoprevention
of skin cancer, versus placebo, applied every night for 6 months in solid organ transplant
recipients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05860881
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kiarash Khosrotehrani, MD PhD FACD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Melanoma and Skin Cancer Trials Coordinator
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 9022
Fax 0 0
Email 0 0
siroskin@masc.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05860881