NCT00763503已完成2 期
Pharmacokinetic and Pharmacodynamic Study of CD 2027 3µg/g Oily Spray Applied Twice Daily for 3 Weeks Under Conditions of Maximized Use in Adults With Plaque-type Psoriasis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- CD 2027 plasma concentrations
研究概览
简要总结
This is a multicenter, open-label study to assess systemic plasma levels of calcitriol, calcium homeostasis and safety in adults with plaque-type psoriasis under conditions of maximized use of CD 2027 3µg/g oily spray twice daily (6 g daily), applied to 20% of BSA for 3 weeks.
There are a total of six visits: Pre-treatment period (Day -15, Day -8 and Day -1) and Treatment period (Day 1/ Baseline, Day 15 and Day 22).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Diagnosis of plaque-type psoriasis involving 10% - 20% of body surface area (BSA), with a Global Severity Score of at least 3 (moderate)
排除标准
- •Other type of psoriasis (other than plaque)
- •Significant abnormal lab findings
- •Secondary hyperparathyroidism
- •Vit D deficiency
- •Hypercalcemia
研究组 & 干预措施
CD 2027
Experimental
干预措施: CD 2027 (Drug)
结局指标
主要结局
CD 2027 plasma concentrations
时间窗: 0, 1, 2, 3, 4, 6, 9, 12 hour time points
次要结局
- Calcium homeostasis(Screening, Day -8, -1 and prior to the morning application on Day 1, 15 and 22)
研究者
研究点 (3)
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