Trial of Sirolimus cream to prevent skin cancers in organ transplant recipients.

Trial of topical Sirolimus, an mTOR pathway inhibitor, to prevent skin cancers in solid organ transplant recipients.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001961235

Enrollment

Registered

2018-12-04

Start date

2019-01-25

Completion date

2019-07-22

Last updated

2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine whether a cream (Sirolimus) is both safe and effective in reducing the burden of skin cancer in transplant recipients. Who is it for? You may be eligible for this study if you are an adult who has received a solid organ transplant more than 12 months ago, and have been affected by many BCCs or SCCs. Study details All participants will apply the Sirolimus cream to one forearm and the placebo cream to the other forearm but they will not know the difference between each cream. Creams will be applied every night for 12 weeks. Participants in this study will be followed up over 24 weeks to assess for any changes in skin lesions via photographs, skin biopsies and blood tests. It is hoped that this research will help determine whether Sirolimus can be effective at preventing skin cancers in transplant recipients.

Interventions

Sirolimus 1% in a gel mixing ethanol and carboxyvinyl polymer will be applied by the participant nightly for 12 weeks on the dorsum of one hand and wrist while the other hand and wrist receives the vehicle (placebo) only. The creams will be applied in a thin layer only, approximately the size of a pea. Participants will be asked to return the tube at the end of the 12 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Solid organ transplant patients will be considered if (1) they received their transplanted organ more than 12 months previously and (2) they have experienced at least 5 SCC/BCCs in the past 5 years and have at least 5 keratotic lesions on the dorsum (back) of each forearm at inclusion.

Exclusion criteria

We will exclude patients who are receiving or have received Sirolimus orally, those who have received a topical field therapy (e.g. Efudex or Aldara) in the past 6 months or those who are medically unstable. We will also exclude patients if any cancer lesion requiring treatment, or any open wound, is detected on the areas to be treated and evaluated. In particular, the study will not exclude any other form of systemic preventive treatment such as acitretin or nicotinamide.

Outcome results