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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05860881
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT05860881
Ethics application status
Date submitted
8/05/2023
Date registered
16/05/2023
Date last updated
8/10/2024
Titles & IDs
Public title
Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)
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Scientific title
A Randomised Double-blind Placebo-controlled Trial of Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients
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Secondary ID [1]
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01.21 SiroSkin
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Universal Trial Number (UTN)
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Trial acronym
SiroSkin
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Organ Transplant Recipients
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Skin Cancer
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Condition category
Condition code
Cancer
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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
Treatment: Drugs - Sirolimus Topical Cream
Other interventions - Placebo
Experimental: Topical Sirolimus - Topical 1% sirolimus cream applied daily to the face for 24 weeks
Placebo comparator: Placebo - Topical placebo cream applied daily to the face for 24 weeks
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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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KC development
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Assessment method [1]
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The number of keratinocyte carcinomas (KCs) on the treated area compared with placebo, at the completion of 24 weeks of topical 1% sirolimus then at 12 and 24 months.
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Timepoint [1]
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2 years
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Secondary outcome [1]
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The occurrence of KCs
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Assessment method [1]
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The occurrence of keratinocyte carcinomas (KCs) on the treated area at the completion of 24 weeks of topical 1% sirolimus then at 12 and 24 months follow up.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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The number of biopsy-proven SCCs
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Assessment method [2]
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The number of biopsy-proven squamous cell carcinomas (SCCs) at the completion of 24 weeks of topical 1% sirolimus, then at 12 and 24 months follow up on the treated area.
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Timepoint [2]
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2 years
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Secondary outcome [3]
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The occurrence of biopsy-proven squamous cell carcinomas (SCCs)
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Assessment method [3]
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The occurrence of biopsy-proven squamous cell carcinomas (SCCs) at the completion of 24 weeks of topical 1% sirolimus, then at 12 and 24 months follow up on the treated area.
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Timepoint [3]
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2 years
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Secondary outcome [4]
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The number of IECs, BCCs and subtypes of SCCs or BCCs
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Assessment method [4]
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The number of intraepidermal carcinomas (IECs), basal cell carcinomas (BCCs) and subtypes of squamous cell carcinomas (SCCs) or BCCs at each of the aforementioned time-points on the treated area.
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Timepoint [4]
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2 years
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Secondary outcome [5]
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The occurrence of IECs, BCCs and subtypes of SCCs or BCCs
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Assessment method [5]
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The occurrence of intraepidermal carcinomas (IECs), BCCs and subtypes of squamous cell carcinomas (SCCs) or basal cell carcinomas (BCCs) at each of the aforementioned time-points on the treated area.
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Timepoint [5]
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2 years
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Secondary outcome [6]
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The number of AKs
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Assessment method [6]
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The number of facial actinic keratosis of each patient at recruitment compared to 3, 6, 12 and 24 months on photographic images and counts.
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Cost-effectiveness
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Assessment method [7]
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The cost-effectiveness of utilising topical sirolimus therapy on SOTRs in comparison to the current standard of care, being surgical intervention, in the management of KCs.
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Timepoint [7]
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2 years
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Secondary outcome [8]
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The number and occurrence of intervention-related side effects
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Assessment method [8]
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The number and occurrence of intervention-related side effects by reviewing any Urgent Safety Measures (USMs), Suspected Unexpected Serious Adverse Reaction (SUSARs), Serious Adverse events (SAEs) and skin-related AEs occurring up to 30 days post-EOT. Adverse events will be reviewed by type, grade according to CTCAE v5.0 and relatedness to treatment.
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Timepoint [8]
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Up to 30 days post end of treatment
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Secondary outcome [9]
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Compliance
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Assessment method [9]
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The feasibility of the 1% sirolimus treatment in SORTs by reviewing completion of the 24-week application course and the total number of doses applied during the course.
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Timepoint [9]
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6 months
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Secondary outcome [10]
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Quality of life (EQ-5D-5L)
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Assessment method [10]
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To evaluate the participants' experience by monitoring side effects and issuing participant surveys such as the EuroQol 5-dimensional (EQ-5D-5L) questionnaire.The EQ-5D-5L questionnaire is a preference-based measure of health status - commonly used in trial-based economic evaluation and is suited for cancer-specific instruments. This tool contains 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The scoring algorithm for the EQ-5D-5L will use the Australian-based value set resulting in scores between 0 and 1 (1 meaning full health).
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Timepoint [10]
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2 years
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Secondary outcome [11]
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Quality of life (BaSQoL)
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Assessment method [11]
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Quality of life will also be assessed with the Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) questionnaire which covers the experiences of skin cancer treatment, diagnosis-related issues and long-term behavioural changes. There are 16 questions and 5 domains including: behaviours, diagnosis and treatment, worries, appearance, and other people. Each question is scored from 0 to 3 with 0 indicating no impact and 3 indicating strong impact on quality of life. The mean scores for each domain are calculated however, the BaSQoL has no summary score or index. The lower the score the lower the impact of the cancer on the quality of life.
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Timepoint [11]
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2 years
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Eligibility
Key inclusion criteria
1. Be aged 18 years or older and able to provide consent
2. Have received an organ transplant equal to or greater than 12 months prior to consent
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
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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
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 within 2 years
(*)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.
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Study design
Purpose of the study
Prevention
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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)
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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 receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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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
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/01/2024
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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
30/12/2026
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Actual
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Sample size
Target
146
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Westmead Hospital - Westmead
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Recruitment hospital [3]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [4]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [5]
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Skin Health Institute - Carlton
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Recruitment hospital [6]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4032 - Chermside
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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3053 - Carlton
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Recruitment postcode(s) [6]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Melanoma and Skin Cancer Trials Limited
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Monash University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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The University of Queensland
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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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 24 weeks in solid organ transplant recipients.
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Trial website
https://clinicaltrials.gov/study/NCT05860881
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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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Kiarash Khosrotehrani, MD PhD FACD
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Address
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The University of Queensland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Melanoma and Skin Cancer Trials Coordinator
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Address
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Country
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Phone
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+61 3 9903 9022
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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
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05860881
Additional trial details provided through ANZCTR
Accrual to date
140
Recruiting in Australia
Recruitment state(s)
NSW,QLD,VIC
Funding & Sponsors
Primary sponsor
University
Primary sponsor name
Monash University
Primary sponsor address
Wellington Rd, Clayton VIC 3800
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1]
94
Metro South Human Research Ethics Committee
Address [1]
94
199 Ipswich Road, Woolloongabba Qld 4102
Country [1]
94
Australia
Date submitted for ethics approval [1]
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14/04/2023
Approval date [1]
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18/04/2023
Ethics approval number [1]
94
95325
Public notes
Contacts
Principal investigator
Title
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Prof
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Name
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Kiarash Khosrotehrani
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Address
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Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
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Country
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Australia
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Phone
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(07) 3176 2111
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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
Title
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Name
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Melanoma and Skin Cancer Trials Coordinator
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Address
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Country
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Phone
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+61 3 9903 9022
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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
Title
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Name
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Melanoma and Skin Cancer Trials Coordinator
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Address
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Country
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Phone
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+61 3 9903 9022
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Fax
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Email
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[email protected]
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