NCT00925730已完成4 期
Non-comparative Open-label Study to Investigate the Efficacy, Safety and Systemic Exposure of Pimecrolimus in Adult and Pediatric Patients With Moderate to Severe Atopic Dermatitis Treated Topically for 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pimecrolimus blood concentration
研究概览
简要总结
This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream 1% into the blood when applied repeatedly under occlusion (i.e. areas treated wrapped in a plastic film) over 8 days in patients with moderate to severe atopic eczema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 2 - 18 years of age
- •Patients with a diagnosis of moderate to severe atopic dermatitis, assessed by a score ≥ 3 at the Investigator's Global Assessment. AD to involve at least 30% of their body surface area as determined by the rule of nine or the Lund and Browder chart.
排除标准
- •Erythrodermic patients with Netherton's syndrome
- •Patients with known serious adverse reactions or hypersensitivity to any of the excipients of the study medication
- •Patients with a history of cancer, skin malignancy or lymphoproliferative disorders or of immunocompromise, including a positive HIV (ELISA and Western blot), Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Pimecrolimus cream 1%
Experimental
Pimecrolimus
干预措施: Pimecrolimus (Drug)
结局指标
主要结局
Pimecrolimus blood concentration
时间窗: Days 1, 9, 16
次要结局
- Efficacy as assessed by the Eczema Area and Severity Index and the Investigators Global Assessment of disease severity. Efficacy outcomes were of an exploratory nature in this study.(Days 1, 9, 16)
研究者
研究点 (1)
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