5-Fluorouracil and Calcipotriene for Field Treatment of Actinic Keratoses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- To assess the clinical efficacy of 5FU/C to treat Actinic Keratoses
研究概览
简要总结
Combination field therapy with 5-fluorouracil and calcipotriene (5FU/C) has become standard of care among dermatologists for the field treatment of diffuse actinic keratoses (AKs). Data suggest that the addition of calcipotriene elicits a sustained T cell memory allowing for both short and long-term AK clearance. Our objective is to evaluate the efficacy, as well as, document the timing, severity and duration of local cutaneous reactions to topical treatment with 5FU/C for the treatment of AKs.
详细描述
The primary objectives of this study is to determine whether chronic, systemic immunosuppression alters the short and long-term clinical 9 efficacy of 5FU/C, presumably through decreased CD4+ T cell-mediated immune response in the skin.
Our central hypothesis is that SOTRs (Solid Organ Transplant Recipients) exhibit attenuated immunologic activation in response to 5FU/C, resulting in reduced AK clearance and potentially requiring extended duration of treatment compared to their immunocompetent counterparts. To test our hypothesis, we propose the following aims:
Aim 1. To assess the clinical efficacy of 5FU/C to treat AKs.
Our primary endpoint is the percent change from baseline in total AKs at week 9. Secondary endpoints include complete (100%) and partial (75%) clearance of AKs at week 9. These endpoints mirror prior pivotal trials of 5FU/C and will directly evaluate whether immunosuppression reduces clinical efficacy of 5FU/C to treat AKs.1,2
Aim 2. To determine whether extending 5FU/C therapy from 4 days to 8 days improves AK clearance in immunosuppressed patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Individuals 18 years old or older are included
- •Presence of 4 to 15 clinically visible and discrete actinic keratoses in a 100-cm2 contiguous area on the face, non-hair bearing scalp, or the upper extremities (including the hand).
- •Solid organ transplantation (kidney, lung, heart, liver, and/or pancreas) on immunosuppressive medications for at least one year prior to the start of the study
排除标准
- •Active skin cancer
- •Recent use of field cancerization within the preceding 12 months in the field of treatment
- •Use of nicotinamide or vitamin A derivatives (which are systemic agents intended for NMSC prevention).
- •Any records flagged "break the glass" or "research opt out."
- •Allergy or hypersensitivity to 5-Fluorouracil or Calcipotriene or inactive components of compounded product
- •Pregnant and breastfeeding patients
- •Allergy to peanut as some formulation of 5FU may contain peanut oil.
- •Allergy or hypersensitivity to Trolamine-NF, PenDerm Cream Base, and Propylene Glycol
结局指标
主要结局
To assess the clinical efficacy of 5FU/C to treat Actinic Keratoses
时间窗: 9 Weeks
Our primary endpoint is the percent change from baseline in total AKs at week 9. Secondary endpoints include complete (100%) and partial (75%) clearance of AKs at week 9. These endpoints mirror prior pivotal trials of 5FU/C and will directly evaluate whether immunosuppression reduces clinical efficacy of 5FU/C to treat AKs.
次要结局
未报告次要终点
研究者
Nima Gharavi
Principal Investigator
Cedars-Sinai Medical Center