The Therapeutic 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
- 20
- 试验地点
- 1
- 主要终点
- The change of severity of acneform eruption induced by EGFR inhibitors
研究概览
简要总结
The purpose of this study is to evaluate the therapeutic 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 therapeutic 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
- Treatment
- 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
- •Patients who received EGFR inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) for malignant tumors
- •Patients with EGFR inhibitor-associated skin reactions: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE V4.03) Grade 2, 3 Patients
- •Patients who can understand and follow the protocol
- •Patients who spontaneously agreed to the study
排除标准
- •NCI-CTCAE grade 4 patients requiring systemic drug therapy
- •Those with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks for reasons other than EGFR inhibitors
- •Patients with existing acne history
- •Patients who have already received anti-EGFR therapy
研究组 & 干预措施
Repair Control EGF®
EGF cream was applied. Half of face was 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 of face was 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 severity of acneform eruption induced by EGFR inhibitors
时间窗: Baseline, 1 week, 2 weeks, 4 weeks
To evaluate the severity of acneiform eruption, the investigators take a photograph of full face. The number of inflammatory and noninflammatory lesions will be counted and accessed the severity based on the Korean Acne Grading System(KAGS).
次要结局
- Patient's global assessment score(Baseline, 1 week, 2 weeks, 4 weeks)
- change of skin hydration(Baseline, 1 week, 2 weeks, 4 weeks)
- change of sebum production(Baseline, 1 week, 2 weeks, 4 weeks)
- Investigator's global assessment score(Baseline, 1 week, 2 weeks, 4 weeks)
- The side effects of product(Baseline, 1 week, 2 weeks, 4 weeks)
研究者
Jung Min Bae
Clinical Assistant Professor
The Catholic University of Korea