NCT02933528已完成2 期
An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS in Patients With Moderate to Severe Scalp 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
- 24
- 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 Maximal Use Treatment with DSXS .
详细描述
Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis. Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant, non-lactating females 18 years of age or older.
- •IRE-approved, signed informed consent form that 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 product
Experimental
treatment with DSXS once daily for 28 days
干预措施: DSXS Topical product (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 stimulation
次要结局
未报告次要终点
研究者
研究点 (1)
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