NCT01806935已完成不适用
Xerotic Dermatitis in Aged People
Pierre Fabre Medical Devices14 个研究点 分布在 1 个国家目标入组 442 人开始时间: 2013年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 442
- 试验地点
- 14
- 主要终点
- Itching symptoms intensity change
研究概览
简要总结
The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 70 years
- •With xerotic dermatitis, clinically assessed ,
- •At least on the anterior part of lower and/or upper limbs,
- •Presenting itching xerotic dermatitis evolving from at least 3 weeks
- •Intensity of itching ≥ 4 on VAS (0-10) at th inclusion time
- •With MMSE score ≥ 20 dating less than 6 months
- •Affiliated to a social security system, or is a beneficiary (as applicable in the national regulation)
排除标准
- •Criteria related to pathologies
- •Severe form of other dermatitis requiring either systemic treatment
- •- Itching xerotic dermatitis from iatrogenic origins
- •Dermatological disease other than xerotic dermatitis which could interfere with the assessment,
- •Systemic disease that may generate xerotic dermatitis and /or pruritus
- •Immunosuppression condition,
- •History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.
- •Criteria related to treatment
- •Use of treatment which could interfere with the evaluation of the disease or the course of the disease
- •Criteria related to the population
- •Ongoing participation to another clinical trial or participation in the previous month before the inclusion
- •Patient under guardianship or trusteeship
结局指标
主要结局
Itching symptoms intensity change
时间窗: From Day 1 to 28 days
次要结局
未报告次要终点
研究者
研究点 (14)
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