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Clinical Trials in Australia / NCT05860881
Active, not recruiting Phase 3

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

NCT05860881 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2024-02-09
Last updated
2025-09-09

Condition(s) studied

Solid Organ Transplant RecipientsSkin Cancer

Investigational drug(s) / intervention(s)

Sirolimus Topical Cream →Placebo

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

Placebo: Cream containing only the base, or vehicle.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 or have a history of keratinocyte cancer on the face in the past 5 years 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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Royal Prince Alfred Hospital Camperdown New South Wales
Westmead Hospital Westmead New South Wales
The Prince Charles Hospital Chermside Queensland
Princess Alexandra Hospital Woolloongabba Queensland
Skin Health Institute Carlton Victoria
The Alfred Hospital Melbourne Victoria

More Melanoma and Skin Cancer Trials Limited trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05860881 on ClinicalTrials.gov ↗ ← All trials in Australia