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Active, Not Recruiting

NCT Number: NCT05860881

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Solid Organ Transplant Recipients Neoplasms Neoplasms by Site Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be aged 18 years or older and able to provide consent
  • Have received an organ transplant equal to or greater than 12 months prior to consent
  • Have had at least 1 SCC/BCC in the past 5 years
  • Have at least 5 keratotic lesions on their face at inclusion or have a history of keratinocyte cancer on the face in the past 5 years

Exclusion criteria

  • Are currently receiving sirolimus or everolimus orally*
  • Have a skin cancer on their face requiring excisional surgery**
  • Have an open wound on their face requiring treatment
  • Are pregnant or planning to become pregnant in the next 6 months
  • Anticipate elective medical events which may prevent daily cream application.
  • Are unable to provide informed consent, complete questionnaires and attend trial site for visits
  • Are participating in another clinical trial with an investigational drug/device aiming to reduce skin cancers or affect level of immunosuppression
  • 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.

Treatment and study plan

Sirolimus Topical Cream

Drug

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

Other names: Rapamycin

Placebo

Other

Cream containing only the base, or vehicle.

Other names: Vehicle alone

Primary outcomes

  1. KC development

    Time frame: 2 years

    The number of keratinocyte carcinomas (KCs) on the treated area compared with placebo, at the completion of 24 weeks of topical 1% sirolimus then at 12 and 24 months.

Secondary outcomes

  1. The occurrence of KCs

    Time frame: 2 years

    The occurrence of keratinocyte carcinomas (KCs) on the treated area at the completion of 24 weeks of topical 1% sirolimus then at 12 and 24 months follow up.

  2. The number of biopsy-proven SCCs

    Time frame: 2 years

    The number of biopsy-proven squamous cell carcinomas (SCCs) at the completion of 24 weeks of topical 1% sirolimus, then at 12 and 24 months follow up on the treated area.

  3. The occurrence of biopsy-proven squamous cell carcinomas (SCCs)

    Time frame: 2 years

    The occurrence of biopsy-proven squamous cell carcinomas (SCCs) at the completion of 24 weeks of topical 1% sirolimus, then at 12 and 24 months follow up on the treated area.

  4. The number of IECs, BCCs and subtypes of SCCs or BCCs

    Time frame: 2 years

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

  5. The occurrence of IECs, BCCs and subtypes of SCCs or BCCs

    Time frame: 2 years

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

  6. The number of AKs

    Time frame: 2 years

    The number of facial actinic keratosis of each patient at recruitment compared to 3, 6, 12 and 24 months on photographic images and counts.

  7. Cost-effectiveness

    Time frame: 2 years

    The cost-effectiveness of utilising topical sirolimus therapy on SOTRs in comparison to the current standard of care, being surgical intervention, in the management of KCs.

  8. The number and occurrence of intervention-related side effects

    Time frame: Up to 30 days post end of treatment

    The number and occurrence of intervention-related side effects by reviewing any Urgent Safety Measures (USMs), Suspected Unexpected Serious Adverse Reaction (SUSARs), Serious Adverse events (SAEs) and skin-related AEs occurring up to 30 days post-EOT. Adverse events will be reviewed by type, grade according to CTCAE v5.0 and relatedness to treatment.

  9. Compliance

    Time frame: 6 months

    The feasibility of the 1% sirolimus treatment in SORTs by reviewing completion of the 24-week application course and the total number of doses applied during the course.

  10. Quality of life (EQ-5D-5L)

    Time frame: 2 years

    To evaluate the participants' experience by monitoring side effects and issuing participant surveys such as the EuroQol 5-dimensional (EQ-5D-5L) questionnaire.The EQ-5D-5L questionnaire is a preference-based measure of health status - commonly used in trial-based economic evaluation and is suited for cancer-specific instruments. This tool contains 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The scoring algorithm for the EQ-5D-5L will use the Australian-based value set resulting in scores between 0 and 1 (1 meaning full health).

  11. Quality of life (BaSQoL)

    Time frame: 2 years

    Quality of life will also be assessed with the Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) questionnaire which covers the experiences of skin cancer treatment, diagnosis-related issues and long-term behavioural changes. There are 16 questions and 5 domains including: behaviours, diagnosis and treatment, worries, appearance, and other people. Each question is scored from 0 to 3 with 0 indicating no impact and 3 indicating strong impact on quality of life. The mean scores for each domain are calculated however, the BaSQoL has no summary score or index. The lower the score the lower the impact of the cancer on the quality of life.

Sponsors and collaborators

Lead sponsor

Melanoma and Skin Cancer Trials Limited

Other

Collaborators

  • Monash University
  • The University of Queensland

Registry information

Official study title

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

Acronym: SiroSkin

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 16, 2023
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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