JPRN-jRCTs021180037已完成2 期
An exploratory study on the usefulness of topical benzoxyl peroxide for prolonged acneiform eruption by EGFR inhibitors
Tsuchiyama Kenichiro0 个研究点目标入组 14 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
Our findings suggest that topical BPO may be effective in treating prolonged AfE caused by EGFR inhibitors. The efficacy and safety of BPO treatment was confirmed by the improved grades of acneiform eruption severity, improved quality of life, and fewer side effects. Although, the frequency of irritation dermatitis and dry skin due to topical BPO was high, there was no problem with tolerability. As treatments for prolonged AfE have not yet been developed, randomized trials are needed to evaluate the effecti
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •(1) Either patient who meet one of the following criteria ((a)(b)(c)).
- •(a) Patients who have non-small cell carcinoma and have received EGFR inhibitors (erlotinib, afatinib, gefitinib). EGFR inhibitors is scheduled to continue for more than 8 weeks.
- •(b) Patients who have colorectal cancer and have received EGFR inhibitors (cetuximab, panitumumab). EGFR inhibitors is scheduled to continue for more than 8 weeks.
- •(c) Patients who have head and neck cancer and have received EGFR inhibitors (cetuximab).EGFR inhibitors is scheduled to continue for more than 8 weeks.
- •(2) Patients, who diagnosed as acneiform eruption and received treatment of topical steroid with or without oral tetracycline, persist the eruption on the face even after 10 or more weeks after the start of EGFR inhibitors.
- •(3) ECOG performance status (PS) at the time of registration is 0 or 1.
排除标准
- •(1) Oral tetracycline (MINO or DOXY) has been started within 4 weeks for the treatment of acneiform eruption.
- •(2) Oral steroids are administrated for the treatment of acneiform eruption.
- •(3) Patient has skin lesion of skin metastatic lesions, burns, frostbite, trauma, scars and/or other lesions to be difficult to evaluate skin symptoms on the test area.
- •(4) Patient has erosions, wounds, etc. that are problematic in applying benzoyl peroxide: BPO gel to the test area.
- •(5) Patient has a history of hypersensitivity to BPO.
- •(6) Pregnant women, women who has possibility of pregnant, woman within 28 days after childbirth, or woman who in breastfeeding.
- •(7) Patient who is considered to have difficulty participating in research by merging psychosis or psychiatric symptoms.
- •(8) Patient who researchers deem that research participation is inappropriate.
研究者
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