NCT01097850撤回2 期
Prospective Randomized Controlled Open-label Trial of a Topical Henna Preparation for the Treatment of Hand-Foot Skin Syndrome and Its Associated Symptoms
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- • To compare the severity of HFS in subjects receiving topical natural henna paste treatment along with using CeraVe™ moisturizing cream concurrently on the treatment side and using only CeraVe™ moisturizing cream on the control side.
研究概览
简要总结
The purpose of this study is to determine whether henna paste is effective in the treatment of hand-foot skin syndrome, induced by the drugs Capecitabine and pegylated liposomal doxorubicin.
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
- 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
- 否
入选标准
- •Patients receiving capecitabine and/or pegylated liposomal doxorubicin as monotherapy or in combination with other agents
- •New diagnosis of active hand-foot skin reaction (on bilateral hands and/or bilateral feet) of 1-3 toxicity as defined by the NCI-CTCAE version 4.0 grading scale with onset of symptoms within the last thirty days
- •Patients must be 18 years or older
- •Patients must provide written informed consent to participate in the study
排除标准
- •Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results
- •Known allergy to natural henna
- •Patients with a previous history of HFS
- •History of G6PD deficiency as determined by screening bloodwork
研究组 & 干预措施
Right
Other
Application of henna paste to right hand/foot plus CeraVe moisturizer
干预措施: henna paste (Drug)
Left
Other
Application of henna paste to the left hand/foot plus CeraVe moisturizer
干预措施: henna paste (Drug)
结局指标
主要结局
• To compare the severity of HFS in subjects receiving topical natural henna paste treatment along with using CeraVe™ moisturizing cream concurrently on the treatment side and using only CeraVe™ moisturizing cream on the control side.
时间窗: 3 weeks
次要结局
- To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire(3 weeks)
研究者
Dennis West
Professor in Dermatology and Pediatrics
Northwestern University
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