Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)

Skin Cancer Clinical Trial

— SiroSkin  

Official title:

A Randomised Double-blind Placebo-controlled Trial of Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05860881
• Other study ID #: 01.21 SiroSkin
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 31, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: October 2023
• Source: Melanoma and Skin Cancer Trials Limited
• Contact: Melanoma and Skin Cancer Trials Coordinator
• Phone: +61 3 9903 9022
• Email: siroskin[@]masc.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 6 months in solid organ transplant recipients.

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 6 months. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 146
• Est. completion date: December 30, 2026
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Skin Cancer
• Solid Organ Transplant Recipients

Intervention

Drug:
• 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:
• Placebo
Cream containing only the base, or vehicle.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Skin Health Institute	Carlton	Victoria
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (3)

Lead Sponsor	Collaborator
Melanoma and Skin Cancer Trials Limited	Monash University, The University of Queensland

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KC development	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.	4 years
Secondary	Number of biopsy-proven SCC	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.	4 years
Secondary	Occurrence of biopsy-proven SCC	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.	4 years
Secondary	The number of intraepidermal carcinomas	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.	4 years
Secondary	The occurrence of intraepidermal carcinomas	The occurrence of intraepidermal carcinomas (IECs), BCCs and subtypes of SCCs or BCCs at each of the aforementioned time-points on the treated area.	4 years
Secondary	Number of facial actinic keratosis	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.	4 years
Secondary	Cost-effectiveness	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.	4 years
Secondary	Intervention-related side effects	Number and occurrence of intervention-related side effects, by type	3.5 years
Secondary	Number of doses	The average number of doses of topical sirolimus (or placebo for the placebo arm) applied during the 24 weeks.	6 months
Secondary	Completion rate	The percentage of patients who complete the 24-week course of treatment.	6 months
Secondary	Intervention completion	The percentage of patients who complete the 24-week course of treatment.; The percentage of patients who complete the 24-week course of treatment	6 months

External Links

•   Detailed information on the SiroSkin trial