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)
KC development — 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.
Trial sites (6)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.