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

Launched by MELANOMA AND SKIN CANCER TRIALS LIMITED · May 8, 2023

Keywords

ClinConnect Summary

The SiroSkin trial is studying how well a cream containing sirolimus can help prevent skin cancer in people who have received solid organ transplants, like a kidney or liver. This phase 3 clinical trial compares the sirolimus cream to a placebo (a cream with no active medicine) and involves applying it to the face every night for 24 weeks. The goal is to see if this treatment can help reduce the risk of developing squamous cell carcinomas (a type of skin cancer) in these patients.

To participate in this trial, individuals must be at least 18 years old and have had an organ transplant at least a year ago. They should also have a history of skin cancers or at least five specific skin lesions on their face. Participants in the trial can expect to apply the cream nightly and attend regular check-ups, while also completing questionnaires about their health. It’s important to know that those currently taking certain medications or with specific skin conditions may not be eligible to join. This study could provide valuable information on how to protect transplant recipients from skin cancer.

Gender

ALL

Eligibility criteria

• 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
• 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.