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临床试验/NCT01349556
NCT01349556撤回不适用

Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pre-treatment With Topical Tretinoin

Johns Hopkins University0 个研究点开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
主要终点
EGFRi rash severity

研究概览

简要总结

This research is being done to study whether using of topical tretinoin can help prevent the common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I) medications such ascetuximab or erlotinib.

Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on their face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and topical or oral antibiotics. However, there has not yet been a study looking at a way to prevent this common side effect from occurring, and topical tretinoin may be useful in reducing the rash.

Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing rashes associated with EGFR-I's.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or over
  • Scheduled to begin treatment with an EGFR inhibitor drug

排除标准

  • Pregnant or nursing
  • History of bleeding disorder
  • History of keloids or large, thick, puffy-looking scars in the last 10 years
  • Used topical retinoids in the last year (e.g. tretinoin/Retin-A, adapalene/Differin, tazarotene/Tazorac)

研究组 & 干预措施

Tretinoin pre-treatment

Experimental

干预措施: Tretinoin (Drug)

结局指标

主要结局

EGFRi rash severity

时间窗: 8 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Chien

Assistant Professor, Co-Director, Cutaneous Translational Research Program

Johns Hopkins University

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