Trial of Sirolimus cream to prevent skin cancers in organ transplant recipients.
- Conditions
- Basal cell carcinomaSquamous cell carcinomaKeratinocyte cancerCancer - Non melanoma skin cancer
- Registration Number
- ACTRN12618001961235
- Lead Sponsor
- niversity of Queensland Diamantina Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 19
Solid organ transplant patients will be considered if (1) they received their transplanted organ more than 12 months previously and (2) they have experienced at least 5 SCC/BCCs in the past 5 years and have at least 5 keratotic lesions on the dorsum (back) of each forearm at inclusion.
We will exclude patients who are receiving or have received Sirolimus orally, those who have received a topical field therapy (e.g. Efudex or Aldara) in the past 6 months or those who are medically unstable. We will also exclude patients if any cancer lesion requiring treatment, or any open wound, is detected on the areas to be treated and evaluated. In particular, the study will not exclude any other form of systemic preventive treatment such as acitretin or nicotinamide.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The composite primary outcome measure is the change in the surface and number of keratotic lesions at each time-point, as compared to initiation day, on photographic images.[Baseline, weeks 4,8,12 and 24 post commencement of topical Sirolimus/placebo.]
- Secondary Outcome Measures
Name Time Method