The Preventive Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change of acneiform eruption caused by use of EGFR inhibitor
研究概览
简要总结
The purpose of this study is to evaluate the preventive efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors.
详细描述
Epidermal growth factor receptor(EGFR) is involved in cell proliferation and is overexpressed or abnormally activated in malignant tumors originating from the colon, breast, ovary, pancreas, and lung. EGFR tyrosine kinase inhibitor(TKI), gefitinib, erlotinib, and afatinib have been for the treatment of cancer associated with EGFR gene mutation. In addition, monoclonal antibodies to EGFR, such as cetuximab and panitumumab, have been used as a chemotherapy for rectal cancer without ras gene mutation and advanced head and neck cancer.
The incidence of cutaneous toxicity of EGFR inhibitors is reported to be 75-80%. Clinical features include acneform folliculitis, xerosis, paronychia, and itching. Of these, about 10% of patients with Grade 3 or greater have a detrimental effect on quality of life and adherence to treatment, resulting in impaired therapeutic results.
There have been many attempts to prevent or treat such skin toxicity. However, there has been no scientifically proven treatment until now.
There is a growing interest in the role of EGF emulsifiers in the treatment of skin adverse effects of EGFR inhibitors, as a result of studies that improve acne significantly compared to placebo.
The purpose of this study is to evaluate the preventive efficacy of EGF cream in the treatment of skin adverse effects in patients with malignant tumors treated with EGFR inhibitor (TKI or monoclonal antibody).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 20 years old
- •Patients scheduled to receive EGFR inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) as malignant tumors
- •Patients who can understand and follow the protocol
- •Patients who spontaneously agreed to the study
排除标准
- •Patients with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks of other skin disorders
- •Patients with existing acne history
- •Breastfeeding or pregnant women
- •Patients who are deemed unsuitable for the examination by the researcher's judgment
研究组 & 干预措施
Repair Control EGF®
EGF cream was applied. One half side of face and one hand were treated with emollient containing EGF.
干预措施: Repair Control EGF® (Drug)
Cream without rhEGF
Placebo cream without EGF was applied. The other half side of face and the other hand were treated with only emollient which was not containing EGF.
干预措施: Cream without rhEGF (Drug)
结局指标
主要结局
The change of acneiform eruption caused by use of EGFR inhibitor
时间窗: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
To evaluate the development and severity of acneiform eruption, the investigators take a photograph of full face and hands on every visit. If the acneiform eruption develop, the severity will be assessed based on the Korean Acne Grading System(KAGS).
次要结局
- the change of skin hydration(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks)
- the change of sebum production(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks)
- The side effects of product(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks)
- Investigator's global assessment score(Baseline, 8 weeks)
- the change paronychia caused by use of EGFR inhibitor(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks)
- Patient's global assessment score(Baseline, 8 weeks)
研究者
Jung Min Bae
Clinical Assistant Professor
The Catholic University of Korea