Clinical Trials Logo

Clinical Trial 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 6 months in solid organ transplant recipients.


Clinical Trial Description

Keratinocyte carcinomas are a major burden affecting mortality and morbidity in solid organ transplant recipients (SOTRs). Due to an increased prevalence of skin cancers, SOTRs require recurrent skin checks and frequent skin cancer surgery. The gold standard of treatment is surgery, enabling complete remission and a cure in the majority of cases. Despite this, there is no effective way of preventing new cancers from developing in the same area. Oral sirolimus is a selective immunosuppressant agent which has proven to reduce the burden of skin cancer; however, it is poorly tolerated due to side effects. Topical sirolimus has proven effective in reducing the skin cancer burden in animal models and is safe on the face of patients with tuberous sclerosis. An initial 12-week phase II clinical trial recently conducted by the research team suggested topical sirolimus to be safe and effective, as it reduced the early signs of skin cancer without any major side effects. In this phase III randomised, double-blind, placebo-controlled study, we propose using 1% topical sirolimus applied to the face on a regular basis for 6 months. We aim to determine whether this topical cream can fill a major gap in our current therapies by reducing the onset of new skin cancers and therefore reduce the burden of disease in terms of number of biopsies and surgeries, and potential hospitalisations and death. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05860881
Study type Interventional
Source Melanoma and Skin Cancer Trials Limited
Contact Melanoma and Skin Cancer Trials Coordinator
Phone +61 3 9903 9022
Email siroskin@masc.org.au
Status Not yet recruiting
Phase Phase 3
Start date October 31, 2023
Completion date December 30, 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02721459 - XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma Phase 1
Completed NCT03740815 - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection N/A
Recruiting NCT05779423 - Cryoablation+Ipilimumab+Nivolumab in Melanoma Phase 2
Terminated NCT01468818 - Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma Phase 2
Completed NCT01820234 - Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event N/A
Completed NCT00535769 - Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use Phase 0
Completed NCT00526032 - Melanoma Detection by Oblique-Incidence Optical Spectroscopy N/A
Completed NCT00588341 - Phase II Trial of Neoadjuvant Temozolomide in Melanoma Patients With Palpable Stage III or IV Disease Undergoing Complete Surgical Resection Phase 2
Active, not recruiting NCT01447199 - The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)
Enrolling by invitation NCT04758988 - AI Augmented Training for Skin Specialists N/A
Not yet recruiting NCT04534868 - Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area N/A
Recruiting NCT04138342 - Topical Fluorescent Nanoparticles Conjugated Somatostatin Analog for Suppression and Bioimaging Breast Cancer Phase 1
Completed NCT03673917 - Cosmetology Students and Skin Cancer N/A
Recruiting NCT04341064 - Sun-safe Habits Intervention and Education Phase 3
Completed NCT04206995 - Cancer Sensing: Evaluation of Odour Sampling Techniques
Recruiting NCT05574101 - A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer Phase 2
Completed NCT05146622 - Virtual Sun Safe Workplaces Ph I
Recruiting NCT05068310 - Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors
Recruiting NCT03889899 - Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia. N/A
Withdrawn NCT04099446 - A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer