SiroSkin

Topical cream to reduce facial skin cancers in organ transplant recipients

Immunosuppression therapies allow many solid organ transplant recipients to live longer and healthier lives, but they also increase the risk of skin cancer in these patients.

In Australia, the high incidence of basal and squamous cell carcinomas, particularly on the head and neck, can translate into numerous skin cancers for solid organ transplant recipients. These skin cancers often require excision and can lead to hundreds of surgeries in the patient’s lifetime. For some patients, these skin cancers metastasise and lead to death.

Currently, patient management does not prevent new or additional skin cancers from occurring. As solid organ transplant patients are considered high risk, effective treatments to stop the onset of new cancers are not implemented. For example, oral Sirolimus can reduce the onset of squamous cell carcinomas by up to 50 per cent but this medication can also cause serious adverse events.

Clinical trial to test effectiveness

To help find an effective treatment for facial skin cancers in solid organ transplant recipients, the SiroSkin clinical trial is investigating whether topical Sirolimus can reduce the number of facial squamous cell carcinomas in these patients.

Topical Sirolimus has been used safely on the face of adult and paediatric patients for other indications for many months without major side effects. The SiroSkin trial is based on clinical experience and a pilot feasibility and safety trial that has been conducted over the past two years.

If topical Sirolimus is successful at preventing new and additional facial squamous cell carcinomas, as it was in the pilot phase, the evidence from this trial will allow a paradigm shift in the management of solid organ transplant recipients, and significantly reduce the burden of skin cancers on these patients.

Trial participants will apply Sirolimus or a placebo to the face and ears each night for six months. If the trial is successful, the placebo group will be offered the treatment for six months.

Participants sought from around Australia

Around 150 participants from around Australia will join SiroSkin, which is a multicentre, randomised, double-blind, placebo-controlled trial.

This trial is largely supported by the transplant recipient community. Trial participants will be enrolled from all major organ transplantation centres in Brisbane, Sydney and Melbourne, where effective skin surveillance is a routine part of their care.

Participants will be stratified for disease burden and current chemopreventive regimens. Benefits in terms of skin cancers and health economics will also be evaluated.

This trial is supported by the Australian Government through the Medical Research Future Fund.

Eligibility

Individuals must be 18 years or older
Have received an organ transplant at least 12 months ago
Have had at least one basal and squamous cell carcinoma in the past five years
Have at least five keratotic lesions on their face / ears

What's involved?

Participants will either receive the topical Sirolimus or a placebo and be asked to apply the cream to the face and ears once nightly for six months. Patients will be followed at six, 12- and 24-months post-completion of the intervention.

At the start and completion of the trial, photos of the participant’s face will be taken to count the number of skin cancers. Participants will also complete a quality of life questionnaire related to skin cancer and health economics at the start or the trial and at six and 24 months.

Why should I join the SiroSkin trial?

In Australia, there are approximately 12,000 solid organ transplant recipients and around 1600 new transplants occur each year. These patients experience a high incidence of skin cancers, which results in a major dependence on regular skin checks and surgeries. It is estimated that skin cancer management for solid organ transplant recipients can cost over $6000 annually, in addition to lost hours of work.

By participating in this trial, you could contribute to the establishment of a new therapy that has minimal side effects but has tremendous opportunity to significantly reduce the amount of facial skin cancers experienced by solid organ transplant recipients. The SiroSkin trial could dramatically improve the long-term outcomes for these patients as topical Sirolimus may improve quality of life and life expectancy. The use of this medication in patient management could translate into cost savings within healthcare systems, globally.

SiroSkin Trial Team

Prof Kiarash Khosrotehrani – Study Chair, The University of Queensland
Prof Daniel Chambers, The University of Queensland
A/Prof Helmut Schaider, The University of Queensland
Dr Nicole Isbel, The University of Queensland
Dr Scott McKenzie, The University of Queensland
Prof H. Peter Soyer, The University of Queensland
A/Prof Louisa Gordon, The Council of the Queensland Institute of Medical Research