A Randomised Double-blind Placebo-controlled Trial of Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 146
- 试验地点
- 6
- 主要终点
- KC development
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Topical Sirolimus
Topical 1% sirolimus cream applied daily to the face for 24 weeks
干预措施: Sirolimus Topical Cream (Drug)
Placebo
Topical placebo cream applied daily to the face for 24 weeks
干预措施: Placebo (Other)
结局指标
主要结局
KC development
时间窗: 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.
次要结局
- The occurrence of KCs(2 years)
- The number of biopsy-proven SCCs(2 years)
- The occurrence of biopsy-proven squamous cell carcinomas (SCCs)(2 years)
- The number of IECs, BCCs and subtypes of SCCs or BCCs(2 years)
- The occurrence of IECs, BCCs and subtypes of SCCs or BCCs(2 years)
- The number of AKs(2 years)
- Cost-effectiveness(2 years)
- The number and occurrence of intervention-related side effects(Up to 30 days post end of treatment)
- Compliance(6 months)
- Quality of life (EQ-5D-5L)(2 years)
- Quality of life (BaSQoL)(2 years)