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Transplant patients get new hope: sirolimus cream may stop facial cancers

NCT ID NCT05860881

Disease control Sponsor: Melanoma and Skin Cancer Trials Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tests whether a cream containing sirolimus (rapamycin) can prevent facial skin cancers in people who have received an organ transplant. 146 participants apply the cream or a placebo to their face every night for 6 months. The study counts new skin cancers during treatment and up to 2 years later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sirolimus (rapamycin) cream
What this could lead to
If it works, this could offer a way to reduce skin cancer risk in organ transplant recipients without needing more surgery.
What could go wrong
This is a phase 3 trial, but results are not yet available. The cream may cause skin irritation or not reduce cancer risk significantly. Transplant recipients already take lifelong immunosuppressants, which may limit the effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 146 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 or have a history of keratinocyte cancer on the face in the past 5 years 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.

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Conditions

The condition(s) this trial relates to.

skin cancer skin neoplasm skin squamous cell carcinoma prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Skin cancer Solid organ transplant recipients

Contacts and locations

Locations

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • Skin Health Institute

    Carlton, Victoria, 3053, Australia

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Prince Charles Hospital

    Chermside, Queensland, 4032, Australia

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

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