NCT00810862终止4 期
A 3-Week, Single-Blind, Placebo-Controlled, Within-Patient, Randomized Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children
Children's Hospital of Michigan0 个研究点目标入组 18 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 主要终点
- Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis
研究概览
简要总结
Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African American children aged 2 to 17 years
- •mild to moderate atopic dermatitis
排除标准
- •m-EASI less than 3 at baseline
- •allergy to Elidel or components
- •use of oral steroids, immunosuppressive agents,cytostatics of phototherapy within 4 weeks prior to study.
- •previous continuous or non-continuous use of pimecrolimus or tacrolimus for greater than 11 months within 2 weeks of enrollment.
- •active skin infections.
- •immunocompromised patients.
- •previous history of skin cancer or lymphoma
- •any hypopigmentation in study areas
- •pregnant or breastfeeding
- •participation in another investigational trial
研究组 & 干预措施
Pimecrolimus
Experimental
Pimecrolimus 1% cream
干预措施: pimecrolimus active cream (Drug)
2
Placebo Comparator
Placebo cream over affected study area
干预措施: placebo base cream (Other)
结局指标
主要结局
Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis
时间窗: at baseline, one week and three weeks following treatment initiation
次要结局
- modified IGA score(at baseline, one week and three weeks following initiation of therapy)
- hypopigmentation scale score(baseline, one and three weeks following initiation of treatment)
研究者
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