Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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)
Query!
Scientific title
A Randomised Double-blind Placebo-controlled Trial of Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients
Query!
Secondary ID [1]
0
0
01.21 SiroSkin
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SiroSkin
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Solid Organ Transplant Recipients
0
0
Query!
Skin Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
KC development
Query!
Assessment method [1]
0
0
The percentage of patients who develop keratinocyte carcinomas on the treated area at completion of 6 months of topical 1% sirolimus, then at 12 and 24 months follow up.
Query!
Timepoint [1]
0
0
4 years
Query!
Secondary outcome [1]
0
0
Number of biopsy-proven SCC
Query!
Assessment method [1]
0
0
The percentage of patients who develop biopsy-proven SCC on the treated area at the completion of 6 months of topical 1% sirolimus, then at 12 and 24 months follow up.
Query!
Timepoint [1]
0
0
4 years
Query!
Secondary outcome [2]
0
0
Occurrence of biopsy-proven SCC
Query!
Assessment method [2]
0
0
The occurrence of biopsy-proven SCC at the completion of 6 months of topical 1% sirolimus, then at 12 and 24 months follow up on the treated area.
Query!
Timepoint [2]
0
0
4 years
Query!
Secondary outcome [3]
0
0
The number of intraepidermal carcinomas
Query!
Assessment method [3]
0
0
The percentage of patients who develop intraepidermal carcinomas (IECs), BCCs and subtypes of SCCs or BCCs at each of the aforementioned time-points on the treated area.
Query!
Timepoint [3]
0
0
4 years
Query!
Secondary outcome [4]
0
0
The occurrence of intraepidermal carcinomas
Query!
Assessment method [4]
0
0
The occurrence of intraepidermal carcinomas (IECs), BCCs and subtypes of SCCs or BCCs at each of the aforementioned time-points on the treated area.
Query!
Timepoint [4]
0
0
4 years
Query!
Secondary outcome [5]
0
0
Number of facial actinic keratosis
Query!
Assessment method [5]
0
0
The percentage of patients who experience a reduction in the number of facial actinic keratosis from recruitment to the end of the study (6 months) on photographic images and counts.
Query!
Timepoint [5]
0
0
4 years
Query!
Secondary outcome [6]
0
0
Cost-effectiveness
Query!
Assessment method [6]
0
0
The cost-effectiveness of utilizing topical sirolimus therapy on SOTRs measured by the ratio of the cost of the intervention to the improvement in the primary outcome.
Query!
Timepoint [6]
0
0
4 years
Query!
Secondary outcome [7]
0
0
Intervention-related side effects
Query!
Assessment method [7]
0
0
Number and occurrence of intervention-related side effects, by type
Query!
Timepoint [7]
0
0
3.5 years
Query!
Secondary outcome [8]
0
0
Number of doses
Query!
Assessment method [8]
0
0
The average number of doses of topical sirolimus (or placebo for the placebo arm) applied during the 24 weeks.
Query!
Timepoint [8]
0
0
6 months
Query!
Secondary outcome [9]
0
0
Completion rate
Query!
Assessment method [9]
0
0
The percentage of patients who complete the 24-week course of treatment.
Query!
Timepoint [9]
0
0
6 months
Query!
Secondary outcome [10]
0
0
Intervention completion
Query!
Assessment method [10]
0
0
The percentage of patients who complete the 24-week course of treatment.
The percentage of patients who complete the 24-week course of treatment
Query!
Timepoint [10]
0
0
6 months
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
31/10/2023
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/12/2026
Query!
Actual
Query!
Sample size
Target
146
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [3]
0
0
The Prince Charles Hospital - Chermside
Query!
Recruitment hospital [4]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [5]
0
0
Skin Health Institute - Carlton
Query!
Recruitment hospital [6]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [4]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [5]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [6]
0
0
300 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Melanoma and Skin Cancer Trials Limited
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Monash University
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
The University of Queensland
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05860881
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Kiarash Khosrotehrani, MD PhD FACD
Query!
Address
0
0
The University of Queensland
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Melanoma and Skin Cancer Trials Coordinator
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61 3 9903 9022
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05860881
Download to PDF