Trial Title:
Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)
NCT ID:
NCT05860881
Condition:
Solid Organ Transplant Recipients
Skin Cancer
Conditions: Official terms:
Carcinoma, Squamous Cell
Sirolimus
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Sirolimus Topical Cream
Description:
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
Arm group label:
Topical Sirolimus
Other name:
Rapamycin
Intervention type:
Other
Intervention name:
Placebo
Description:
Cream containing only the base, or vehicle.
Arm group label:
Placebo
Other name:
Vehicle alone
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.
Detailed 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 24 weeks. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Be aged 18 years or older and able to provide consent
2. Have received an organ transplant equal to or greater than 12 months prior to
consent
3. Have had at least 1 SCC/BCC in the past 5 years
4. Have at least 5 keratotic lesions on their face at inclusion
Exclusion Criteria:
1. Are currently receiving sirolimus or everolimus orally*
2. Have a skin cancer on their face requiring excisional surgery**
3. Have an open wound on their face requiring treatment
4. Are pregnant or planning to become pregnant in the next 6 months
5. Anticipate elective medical events which may prevent daily cream application.
6. Are unable to provide informed consent, complete questionnaires and attend trial
site for visits
7. Are participating in another clinical trial with an investigational drug/device
aiming to reduce skin cancers or affect level of immunosuppression
8. Planning to move overseas within 2 years
(*)Patients are eligible to join the study after ceasing treatment and after a washout
period of 16 days for sirolimus and 8 days for everolimus.
(**) Once treatment of the lesion is completed these patients can be re-screened.
Gender:
All
Gender based:
Yes
Gender description:
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test within 7 days (168 hours) prior to their baseline & screening visit (D0) and agree
to use adequate methods of contraception for the duration of drug administration.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Royal Prince Alfred Hospital
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Diona Damian
Email:
Diona.Damian@health.nsw.gov.au
Investigator:
Last name:
Diona Damian
Email:
Principal Investigator
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Nadeeja Atapattu
Email:
Nadeeja.Atapattu@health.nsw.gov.au
Investigator:
Last name:
Pablo Fernandez-Penas
Email:
Principal Investigator
Facility:
Name:
The Prince Charles Hospital
Address:
City:
Chermside
Zip:
4032
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Susan Brown
Email:
s.brown1@uq.edu.au
Investigator:
Last name:
Daniel Chambers
Email:
Principal Investigator
Investigator:
Last name:
Lea Dousset
Email:
Sub-Investigator
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Susan Brown
Email:
s.brown1@uq.edu.au
Investigator:
Last name:
Helmut Schaider
Email:
Principal Investigator
Investigator:
Last name:
Lea Dousset
Email:
Sub-Investigator
Facility:
Name:
Skin Health Institute
Address:
City:
Carlton
Zip:
3053
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Sarah Chivers
Email:
schivers@skinhealthinstitute.org.au
Investigator:
Last name:
Alvin Chong
Email:
Principal Investigator
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Frances Burns
Email:
F.Burns@alfred.org.au
Investigator:
Last name:
Johannes Kern, MD, PhD
Email:
Principal Investigator
Start date:
January 10, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Melanoma and Skin Cancer Trials Limited
Agency class:
Other
Collaborator:
Agency:
Monash University
Agency class:
Other
Collaborator:
Agency:
The University of Queensland
Agency class:
Other
Source:
Melanoma and Skin Cancer Trials Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05860881
https://www.masc.org.au/siroskin/
