Solid Organ Transplant RecipientsPhase 3SiroSkinNCT05860881
Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)
A Phase 3 study testing Sirolimus Topical Cream in people with Solid Organ Transplant Recipients and Skin Cancer, run by Melanoma and Skin Cancer Trials Limited at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Organ Transplant Recipients, Skin Cancer
- What is being tested?
- Sirolimus Topical Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 6 sitesAustralia
- Study dates
- 9 Feb 2024to 30 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged 18 years or older and able to provide consent
- Have received an organ transplant equal to or greater than 12 months prior to consent
- Have had at least 1 SCC/BCC in the past 5 years
- Have at least 5 keratotic lesions on their face at inclusion or have a history of keratinocyte cancer on the face in the past 5 years
Who cannot join
- Are currently receiving sirolimus or everolimus orally*
- Have a skin cancer on their face requiring excisional surgery**
- Have an open wound on their face requiring treatment
- Are pregnant or planning to become pregnant in the next 6 months
- Anticipate elective medical events which may prevent daily cream application.
- Are unable to provide informed consent, complete questionnaires and attend trial site for visits
Show all 10Show fewer
- Are participating in another clinical trial with an investigational drug/device aiming to reduce skin cancers or affect level of immunosuppression
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Skin Health Institute
Carlton, Victoria, 3053
The Prince Charles Hospital
Chermside, Queensland, 4032
The Alfred Hospital
Melbourne, Victoria, 3004
Westmead Hospital
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
Official title: A Randomised Double-blind Placebo-controlled Trial of Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients
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.
Read the detailed description
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.
- Conditions
- Solid Organ Transplant Recipients, Skin Cancer
- Being tested
- Sirolimus Topical Cream, Placebo
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus Topical CreamDrug
Also called Rapamycin
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
PlaceboOther
Also called Vehicle alone
Cream containing only the base, or vehicle.
| Study group | Role | What they receive |
|---|---|---|
| Topical Sirolimus | Experimental | Topical 1% sirolimus cream applied daily to the face for 24 weeks Receives: Drug: Sirolimus Topical Cream |
| Placebo | Placebo comparator | Topical placebo cream applied daily to the face for 24 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start9 Feb 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Organ Transplant RecipientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melanoma and Skin Cancer Trials Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, The University of Queensland
- Responsible party
- Sponsor
- Investigators
- Kiarash Khosrotehrani, MD PhD FACD, Study chair, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860881
- Sponsor's protocol ID
- 01.21 SiroSkin
- Acronym
- SiroSkin
- Status last verified
- Sep 2025
- First submitted
- 8 May 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dousset L, Chambers DC, Webster A, Isbel N, Campbell S, Duarte C, Collins L, Damian D, Tseng A, Karlsen E, Ilinsky OV, Brown S, Schaider H, Soyer HP, Ospino DA, Hogarth S, Chong AH, Mar V, McKenzie S, Gin D, Fernandez-Penas P, Kern JS, Loewe K, Roy E, Herschtal A, Khosrotehrani K. Trial protocol for SiroSkin: a randomised double-blind placebo-controlled trial of topical sirolimus in chemoprevention of facial squamous cell carcinomas in solid organ transplant recipients. Trials. 2024 Nov 22;25(1):789. doi: 10.1186/s13063-024-08619-3.
PubMed 39578921
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Placebo-controlled Trial of Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT05860881
- Acronym / sponsor ID
- SiroSkin / 01.21 SiroSkin
- Conditions
- Solid Organ Transplant Recipients, Skin Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Melanoma and Skin Cancer Trials LimitedUniversity, hospital or other
- Collaborators
- Monash University, The University of Queensland
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Sirolimus | Experimental | Drug: Sirolimus Topical CreamTopical 1% sirolimus cream applied daily to the face for 24 weeks |
| Placebo | Placebo comparator | Other: PlaceboTopical placebo cream applied daily to the face for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be aged 18 years or older and able to provide consent
- Have received an organ transplant equal to or greater than 12 months prior to consent
- Have had at least 1 SCC/BCC in the past 5 years
- Have at least 5 keratotic lesions on their face at inclusion or have a history of keratinocyte cancer on the face in the past 5 years
Key exclusion criteria (10 listed)
- Are currently receiving sirolimus or everolimus orally*
- Have a skin cancer on their face requiring excisional surgery**
- Have an open wound on their face requiring treatment
- Are pregnant or planning to become pregnant in the next 6 months
- Anticipate elective medical events which may prevent daily cream application.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus Topical CreamAlso: RapamycinThe 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 | Drug | Topical Sirolimus |
| PlaceboAlso: Vehicle aloneCream containing only the base, or vehicle. | Other | Placebo |
Primary outcome
KC development
Time frame: 2 years
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.
11 secondary outcomes
The occurrence of KCs
Time frame: 2 years
The number of biopsy-proven SCCs
Time frame: 2 years
The occurrence of biopsy-proven squamous cell carcinomas (SCCs)
Time frame: 2 years
The number of IECs, BCCs and subtypes of SCCs or BCCs
Time frame: 2 years
The occurrence of IECs, BCCs and subtypes of SCCs or BCCs
Time frame: 2 years
The number of AKs
Time frame: 2 years
Cost-effectiveness
Time frame: 2 years
The number and occurrence of intervention-related side effects
Time frame: Up to 30 days post end of treatment
Compliance
Time frame: 6 months
Quality of life (EQ-5D-5L)
Time frame: 2 years
Quality of life (BaSQoL)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Results publication: PubMed 39578921Dousset L, Chambers DC, Webster A, Isbel N, Campbell S, Duarte C, Collins L, Damian D, Tseng A, Karlsen E, Ilinsky OV, Brown S, Schaider H, Soyer HP, Ospino DA, Hogarth S, Chong AH, Mar V, McKenzie S, Gin D, Fernandez-Penas P, Kern JS, Loewe K, Roy E, Herschtal A, Khosrotehrani K. Trial protocol for SiroSkin: a randomised double-blind placebo-controlled trial of topical sirolimus in chemoprevention of facial squamous cell carcinomas in solid organ transplant recipients. Trials. 2024 Nov 22;25(1):789. doi: 10.1186/s13063-024-08619-3.
- Detailed information on the SiroSkin trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiarash Khosrotehrani, MD PhD FACD study chair
The University of Queensland
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sirolimus Topical Cream in people with Solid Organ Transplant Recipients and Skin Cancer, run by Melanoma and Skin Cancer Trials Limited at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KC development (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05860881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.