An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With Topicort® (Desoximetasone) Topical Spray, 0.25% in Pediatric Patients With Plaque Psoriasis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test
研究概览
简要总结
The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.
详细描述
An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative
- •Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp)
- •Physicians Global Assessment score of 3 or 4 at baseline
排除标准
- •Has other dermatological conditions that may interfere with clinical assessments
- •Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results
- •History of an adverse reaction to Cortrosyn™ or similar test reagents
- •Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation
研究组 & 干预措施
Topicort® Topical Spray, 0.25%
Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days
干预措施: Topicort® (desoximetasone) Topical Spray, 0.25% (Drug)
结局指标
主要结局
The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test
时间窗: 28 days
A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria: * their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (\< basal + 7) * the post stimulation level is ≤ 18 mcg/100 ml
次要结局
- Adverse Event(28 days)
- Cpre-ss(28 Days)