An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With DSXS in Patients With Atopic Dermatitis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants With HPA Axis Suppression
研究概览
简要总结
this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.
详细描述
The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.
The secondary objectives are to evaluate to evaluate adverse event (AE) profiles of DSXS administered to 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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a definite clinical diagnosis of stable atopic dermatitis
排除标准
- •Patient is under the age of 2
研究组 & 干预措施
DSXS topical product
treatment with DSXS twice daily for 28 days
干预措施: DSXS (Drug)
结局指标
主要结局
Number of Participants With HPA Axis Suppression
时间窗: 28 days.
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.
次要结局
未报告次要终点