Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Squamous Cell

Facies

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Sirolimus

Temsirolimus

MTOR Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Immunosuppressive Agents

Immunologic Factors

Topical 1% sirolimus cream applied daily to the face for 6 months

Topical placebo cream applied daily to the face for 6 months

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

Sirolimus Topical Cream

Cream containing only the base, or vehicle.

Placebo

Melanoma and Skin Cancer Trials Coordinator

Kiarash Khosrotehrani

Diona Damian

Angela Webster

Susan Brown

Daniel Chambers

Lea Dousset

Helmut Schaider

Sarah Chivers

Alvin Chong

Kiarash Khosrotehrani, MD PhD FACD

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.

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.

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.

Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)

A Randomised Double-blind Placebo-controlled Trial of Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients

The percentage of patients who develop keratinocyte carcinomas on the treated area at completion of 6 months of topical 1% sirolimus, then at 12 and 24 months follow up.

The percentage of patients who develop biopsy-proven SCC on the treated area at the completion of 6 months of topical 1% sirolimus, then at 12 and 24 months follow up.

The occurrence of biopsy-proven SCC at the completion of 6 months of topical 1% sirolimus, then at 12 and 24 months follow up on the treated area.

The percentage of patients who develop intraepidermal carcinomas (IECs), BCCs and subtypes of SCCs or BCCs at each of the aforementioned time-points on the treated area.

The occurrence of intraepidermal carcinomas (IECs), BCCs and subtypes of SCCs or BCCs at each of the aforementioned time-points on the treated area.

The percentage of patients who experience a reduction in the number of facial actinic keratosis from recruitment to the end of the study (6 months) on photographic images and counts.

The cost-effectiveness of utilizing topical sirolimus therapy on SOTRs measured by the ratio of the cost of the intervention to the improvement in the primary outcome.

Number and occurrence of intervention-related side effects, by type

The average number of doses of topical sirolimus (or placebo for the placebo arm) applied during the 24 weeks.

The percentage of patients who complete the 24-week course of treatment.

The percentage of patients who complete the 24-week course of treatment.

The percentage of patients who complete the 24-week course of treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)	NCT05860881	Solid Organ Tra... Skin Cancer	Sirolimus Topic... Placebo	18 Years -	Melanoma and Skin Cancer Trials Limited
Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)	NCT05860881	Solid Organ Tra... Skin Cancer	Sirolimus Topic... Placebo	18 Years -	Melanoma and Skin Cancer Trials Limited
Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)	NCT05860881	Solid Organ Tra... Skin Cancer	Sirolimus Topic... Placebo	18 Years -	Melanoma and Skin Cancer Trials Limited

Spots Global Cancer Trial Database for sirolimus topical cream