Active — Not RecruitingPhase 3

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

Australia146 participantsStarted 2024-02-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Be aged 18 years or older and able to provide consent
✓. Have received an organ transplant equal to or greater than 12 months prior to consent
✓. Have had at least 1 SCC/BCC in the past 5 years
✓. 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

✕. Are currently receiving sirolimus or everolimus orally\*
✕. Have a skin cancer on their face requiring excisional surgery\*\*
✕. Have an open wound on their face requiring treatment
✕. Are pregnant or planning to become pregnant in the next 6 months
✕. Anticipate elective medical events which may prevent daily cream application.
✕. Are unable to provide informed consent, complete questionnaires and attend trial site for visits
✕. Are participating in another clinical trial with an investigational drug/device aiming to reduce skin cancers or affect level of immunosuppression
✕. Planning to move overseas within 2 years

What they're measuring

KC development

Timeframe: 2 years

Trial details

NCT IDNCT05860881

SponsorMelanoma and Skin Cancer Trials Limited

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

View on ClinicalTrials.gov More Solid Organ Transplant Recipients trials