None listed
Conditions
Brief summary
The purpose of this study is to determine whether topical sirolimus cream is able to reduce the occurrence of skin cancer in solid organ transplant recipients who are at high risk. Who is it for? You may be eligible for this study if you are aged 18 years or above. You will also have received an organ transplant 12 months ago or earlier, had previous skin cancer, and have 5 or more keratotic lesions on your face. Study details Participants will be randomly assigned to use either the sirolimus cream or a placebo cream. Participants will apply the cream to their face every night for six months. For monitoring, participants will be asked to visit the clinic at the start of the study, then 3 months and 6 months later and fill out questionnaires at these visits. At the 6-month visit, a blood test will also be done. Participants' health records will also be passively monitored for 24 months. It is hoped that this research will indicate if sirolimus cream is effective in preventing skin cancer, and thus reduce the occurrence of skin cancer in people who are at high risk.
Interventions
Sirolimus 1% cream (in a vehicle) or placebo (vehicle only) will be applied by the participant nightly for six months onto the participants face. This is a double blinded randomised control trial, therefore the participants will not know if they are applying the intervention or placebo. The creams will be applied in a thin layer only, and will be delivered in a pump container to enable standardised delivery of intervention/placebo. The number of successful applications of the cream are assessed
Sirolimus 1% cream (in a vehicle) or placebo (vehicle only) will be applied by the participant nightly for six months onto the participants face. This is a double blinded randomised control trial, therefore the participants will not know if they are applying the intervention or placebo. The creams will be applied in a thin layer only, and will be delivered in a pump container to enable standardised delivery of intervention/placebo. The number of successful applications of the cream are assessed by participants completing a daily record of application. In addition, they are provided the cream in two consecutive 3 month containers which will be returned at three and six months respectively. This enables researchers to monitor adherence through assessing the number of applications on their recording sheet and the amount of product left at three months. Participants will also be reminded to apply the cream through phone calls/messages.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Be aged 18 years or older Have received an organ transplant 12 months ago or earlier Have had least 1 SCC/BCC in the past 5 years Have at least 5 keratotic lesions on their face at inclusion
Exclusion criteria
Are unable to provide informed consent Are currently receiving sirolimus or everolimus orally Have a skin cancer on their face requiring treatment Have an open wound on their face requiring treatment Are pregnant or planning to become pregnant in the next 6 months Are medically unstable Have difficulty understanding and signing the PICF document (are non-English speaking or intellectually impaired) Non-english speaking patients
Outcome results
None listed