NCT02932878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 Plaque Psoriasis
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
- 16
- 试验地点
- 1
- 主要终点
- Proportion 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 (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis
详细描述
To evaluate the potential of DSXS to suppress HPA axis function in patients with mild to moderate plaque psoriasis.
To evaluate the efficacy parameters and adverse event (AE) profile of DSXS administered to patients with mild to moderate plaque psoriasis.
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
- 是
入选标准
- •Male or non pregnant, non lactating females
排除标准
- •Patients under 2 years of age
研究组 & 干预措施
DSXS topical
Experimental
administered twice daily for 28 days
干预措施: DSXS topical (Drug)
结局指标
主要结局
Proportion of Patients in the Study With HPA Axis Suppression
时间窗: 28 Days
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin
次要结局
未报告次要终点
研究者
研究点 (1)
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