NCT02933502已完成2 期
An Open-label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS 1538b Topical Product Applied Once-daily 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
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants 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 DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to SevereScalp Psoriasis
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant, non-lactating females 12-17 years of age.
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
Number of Participants With HPA Axis Suppression
时间窗: day 28
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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