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

NCT05860881 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 01.21 SiroSkin
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Solid Organ Transplant Recipients; Skin Cancer

Outcome Measures

Primary Outcomes (1)

• KC development

  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.

  2 years

Secondary Outcomes (11)

• The occurrence of KCs

  2 years

• The number of biopsy-proven SCCs

  2 years

• The occurrence of biopsy-proven squamous cell carcinomas (SCCs)

  2 years

• The number of IECs, BCCs and subtypes of SCCs or BCCs

  2 years

• The occurrence of IECs, BCCs and subtypes of SCCs or BCCs

  2 years

Study Arms (2)

Topical Sirolimus

EXPERIMENTAL

Topical 1% sirolimus cream applied daily to the face for 24 weeks

Drug: Sirolimus Topical Cream

Placebo

PLACEBO COMPARATOR

Topical placebo cream applied daily to the face for 24 weeks

Other: Placebo

Interventions

Sirolimus Topical Cream DRUG

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

Also known as: Rapamycin

Topical Sirolimus

Placebo OTHER

Cream containing only the base, or vehicle.

Also known as: Vehicle alone

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days (168 hours) prior to their baseline \& screening visit (D0) and agree to use adequate methods of contraception for the duration of drug administration.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• (\*)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.

Sponsors & Collaborators

• Melanoma and Skin Cancer Trials Limited: lead
• Monash University: collaborator
• The University of Queensland: collaborator

Study Sites (6)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Skin Health Institute

Carlton, Victoria, 3053, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• Dousset 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 BACKGROUND

Related Links

• Detailed information on the SiroSkin trial

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Kiarash Khosrotehrani, MD PhD FACD

  The University of Queensland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 16, 2023
• Study Start: February 9, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)