NCT01137032已完成4 期
An Open -Label Study to Evaluate the Effect of Pandel Cream 0.1% on the Hypothalamic Pituitary Adrenal Axis in the Pediatric and Adult Population
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Post-injection Serum Cortisol Level
研究概览
简要总结
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.
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
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body surface area
- •Good health with the exception of psoriasis or atopic dermatitis
排除标准
- •Any disease affecting the HPA-axis
- •Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period
研究组 & 干预措施
Pandel Cream 0.1%
Experimental
Pandel Cream 0.1%
干预措施: Pandel Cream 0.1% (Drug)
结局指标
主要结局
Post-injection Serum Cortisol Level
时间窗: 22 Days
The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.
次要结局
- and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.(22 days)
- Pre-injection Serum Cortisol Levels(22 Days)
研究者
研究点 (3)
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