NCT02932891已完成2 期
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS Topical Product in Patients With Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The Number of Patients in the Study With HPA Axis Suppression
研究概览
简要总结
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS in Patients with Atopic Dermatitis
详细描述
To evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe atopic dermatitis.
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
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent/legal guardian has signed informed consent form, which meets all criteria of current FDA regulations.
排除标准
- •Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy
研究组 & 干预措施
DSXS topical
Experimental
active treatment
干预措施: DSXS topical (Drug)
结局指标
主要结局
The Number of Patients in the Study With HPA Axis Suppression
时间窗: 29 Days
Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator
次要结局
未报告次要终点
研究者
研究点 (1)
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