Clinical trial · Interventional
Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)
A Randomised Double-blind Placebo-controlled Trial of Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients
NCT05860881CI-TRIAL-00094768SiroSkinactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Solid Organ Transplant Recipients | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Sirolimus Topical Cream | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Topical Sirolimus
- description
- Topical 1% sirolimus cream applied daily to the face for 24 weeks
- interventionNames
- Drug: Sirolimus Topical Cream
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Topical placebo cream applied daily to the face for 24 weeks
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- KC development
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTDousset L, Chambers DC, Webster A, Isbel N, Campbell S, Duarte C, Collins L, Damian D, Tseng A, Karlsen E, Ilinsky OV, Brown S, Schaider H, Soyer HP, Ospino DA, Hogarth S, Chong AH, Mar V, McKenzie S, Gin D, Fernandez-Penas P, Kern JS, Loewe K, Roy E, Herschtal A, Khosrotehrani K. Trial protocol for SiroSkin: a randomised double-blind placebo-controlled trial of topical sirolimus in chemoprevention of facial squamous cell carcinomas in solid organ transplant recipients. Trials. 2024 Nov 22;25(1):789. doi: 10.1186/s13063-024-08619-3. PMID 39578921