Double Blind Placebo Controlled Trial, for Evaluating Preventive Therapy With Either Oint Threolone Versus Synthomycine Versus Aqua Cream, for EGFR'I Induced Acneiform Rash
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.
研究概览
简要总结
The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.
详细描述
The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.
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
- Quadruple (Participant, Care Provider, 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
- •Patients who are planed to initiate treatment with either cetuximab , erlotinib, gefitinib or panitumumab.
排除标准
- •Patients who received any facial topical treatment / systemic antibiotics or any anti-inflammatory drug during the 2 weeks prior to study initiation.
- •Known hypersensitivity to ointment Synthomycine or to Threolone.
- •Patients presented with cutaneous rash during the 2 weeks prior to study initiation
研究组 & 干预措施
ointment Threolone
Treatment with topical application of combined anti inflammatory and anti bacterial agent.
干预措施: Threolone ointment (Drug)
ointment Threolone
Treatment with topical application of combined anti inflammatory and anti bacterial agent.
干预措施: ointment Synthomycine (Drug)
ointment Threolone
Treatment with topical application of combined anti inflammatory and anti bacterial agent.
干预措施: Aqua cream (Drug)
ointment Synthomycine
ointment once daily for 1 month
干预措施: ointment Synthomycine (Drug)
ointment Synthomycine
ointment once daily for 1 month
干预措施: Aqua cream (Drug)
Aqua cream
干预措施: Aqua cream (Drug)
结局指标
主要结局
Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.
时间窗: 3 years
次要结局
- Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms(3 years)
研究者
iris amitay
Iris Amitay-Laish, MD
Rabin Medical Center