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

• Status: Not yet recruiting
• Trial end date: 2026-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melanoma and Skin Cancer Trials Limited
• Collaborators: Monash University; The University of Queensland
• Treatments: Sirolimus

Criteria

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.