Four-arm Study to Evaluate Urea 40% Cream, Fluocinonide 0.05% Cream, Tazarotene 0.1% Cream, and an Emollient Cream for the Treatment of Hand-foot Skin Reaction Related to the Use of Multi-targeted Tyrosine Kinase Inhibitor Sorafenib.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Skindex-16 Total Score Between Baseline and 8 Weeks
研究概览
简要总结
The purpose of this study is to evaluate treatments for a rash caused by sorafenib.
详细描述
This study will compare compare the effectiveness of four creams (urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream) in treating hand-foot skin reaction (HFSR), a rash caused by sorafenib.
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
- Double (Participant, Investigator)
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 receiving sorafenib as monotherapy or in combination if other agents are not known to cause HFSR.
- •Subjects must be 18 years or older.
- •Patients must provide written informed consent to participate in the study.
- •Women of childbearing potential and men must be willing to use an effective method of contraception while participating in this study and for at least two weeks after completing treatment in the study.
- •Women in this study need to have a negative urine pregnancy test before starting study medications.
排除标准
- •Patients simultaneously taking another anti-cancer agent or combination of anti-cancer agents known to cause hand foot syndrome (pegylated doxorubicin, 5-fluorouracil, cytarabine).
- •Patients with an active dermatological condition due to previous chemotherapy or biologic therapy affecting the hands.
- •Patients with pre-existing dermatological condition affecting the hands or feet.
- •Women who have a positive pregnancy test or are lactating.
研究组 & 干预措施
urea 40% cream
干预措施: urea 40% cream (Drug)
fluocinonide 0.05% cream
干预措施: fluocinonide 0.05% cream (Drug)
tazarotene 0.1% cream
干预措施: tazarotene 0.1% cream (Drug)
bland emollient cream
干预措施: bland emollient cream (Udderly smooth® Udder Cream) (Drug)
结局指标
主要结局
Change in Skindex-16 Total Score Between Baseline and 8 Weeks
时间窗: baseline and 8 weeks
The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 8 weeks.
次要结局
- Change in Skindex-16 Total Score Between Baseline and 2 Weeks(baseline and 2 weeks)
研究者
Dennis West
Professor in Dermatology
Northwestern University