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

NCT05860881 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-09-09

No results posted yet for this study

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

Interventions

DRUG

Sirolimus Topical Cream

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

OTHER

Placebo

Cream containing only the base, or vehicle.

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • The University of Queensland

    collaborator OTHER

  • Melanoma and Skin Cancer Trials Limited

    lead OTHER

Principal Investigators

  • Kiarash Khosrotehrani, MD PhD FACD · The University of Queensland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-09
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05860881 on ClinicalTrials.gov