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Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)
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.
Study details:
Keratinocyte carcinomas are a major burden affecting mortality and morbidity in solid organ transplant recipients (SOTRs). Due to an increased prevalence of skin cancers, SOTRs require recurrent skin checks and frequent skin cancer surgery. The gold standard of treatment is surgery, enabling complete remission and a cure in the majority of cases.
Despite this, there is no effective way of preventing new cancers from developing in the same area. Oral sirolimus is a selective immunosuppressant agent which has proven to reduce the burden of skin cancer; however, it is poorly tolerated due to side effects. Topical sirolimus has proven effective in reducing the skin cancer burden in animal models and is safe on the face of patients with tuberous sclerosis.
An initial 12-week phase II clinical trial recently conducted by the research team suggested topical sirolimus to be safe and effective, as it reduced the early signs of skin cancer without any major side effects. In this phase III randomised, double-blind, placebo-controlled study, we propose using 1% topical sirolimus applied to the face on a regular basis for 24 weeks. We aim to determine whether this topical cream can fill a major gap in our current therapies by reducing the onset of new skin cancers and therefore reduce the burden of disease in terms of number of biopsies and surgeries, and potential hospitalisations and death.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-01-10
Primary completion: 2026-05-15
Study completion finish: 2026-12-30
Study type
PREVENTION
Phase
PHASE3
Trial ID
NCT05860881
Intervention or treatment
DRUG: Sirolimus Topical Cream
OTHER: Placebo
Conditions
- • Skin Cancer
- • Solid Organ Transplant Recipients
Find a site
Closest Location:
Royal Prince Alfred Hospital
Research sites nearby
Select from list below to view details:
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Topical Sirolimus
| DRUG: Sirolimus Topical Cream
|
PLACEBO_COMPARATOR: Placebo
| OTHER: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
KC development | 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. | 2 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
The occurrence of KCs | 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. | 2 years |
The number of biopsy-proven SCCs | 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. | 2 years |
The occurrence of biopsy-proven squamous cell carcinomas (SCCs) | 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. | 2 years |
The number of IECs, BCCs and subtypes of SCCs or BCCs | 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. | 2 years |
The occurrence of IECs, BCCs and subtypes of SCCs or BCCs | 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. | 2 years |
The number of AKs | The number of facial actinic keratosis of each patient at recruitment compared to 3, 6, 12 and 24 months on photographic images and counts. | 2 years |
Cost-effectiveness | 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. | 2 years |
The number and occurrence of intervention-related side effects | 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. | Up to 30 days post end of treatment |
Compliance | 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. | 6 months |
Quality of life (EQ-5D-5L) | 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). | 2 years |
Quality of life (BaSQoL) | 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. | 2 years |
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