Effect of Calcipotriol Plus Betamethasone Dipropionate Gel on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to 16 Years, 11 Months) With Scalp and Body Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 125
- 试验地点
- 35
- 主要终点
- Change in Albumin-corrected Serum Calcium From Baseline to Week 8
研究概览
简要总结
An international, multi-centre, prospective, non-controlled, open, single-group, 8-week trial in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.
详细描述
A phase 2 trial evaluating the safety and efficacy of once daily use of LEO 80185 gel containing calcipotriol 50 mcg/g plus betamethasone 0.5mg/g (as dipropionate) in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LEO 80185 gel
干预措施: LEO 80185 gel (Drug)
结局指标
主要结局
Change in Albumin-corrected Serum Calcium From Baseline to Week 8
时间窗: From baseline to Week 8
Change in albumin-corrected serum calcium from baseline to Week 8
Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment
时间窗: From baseline to end of treatment
Change in albumin-corrected serum calcium from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.
Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment
时间窗: From baseline to end of treatment
Change in 24-hour urinary calcium excretion from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.
Change in Albumin-corrected Serum Calcium From Baseline to Week 4
时间窗: From baseline to Week 4
Change in albumin-corrected serum calcium from baseline to Week 4
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8
时间窗: 30 minutes after ACTH-challenge at Week 8
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 8
Adverse Drug Reactions (ADRs)
时间窗: 8 weeks
Number of Adverse Drug Reactions (ADRs)
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8
时间窗: From baseline to Week 8
Change in 24-hour urinary calcium excretion from baseline to Week 8
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
时间窗: 30 minutes after ACTH-challenge at Week 4
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4
时间窗: From baseline to Week 4
Change in 24-hour urinary calcium excretion from baseline to Week 4
次要结局
- Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8(From baseline to Week 8)
- Pharmacokinetic Evaluation C(Max)(Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP)
- Percentage Change in PASI From Baseline to End of Treatment(From baseline to end of treatment)
- Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 4(30 and 60 minutes after ACTH-challenge at Week 4)
- Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8(30 and 60 minutes after ACTH-challenge at Week 8)
- Change in Serum Alkaline Phosphatase From Baseline to Week 4(From baseline to Week 4)
- Adverse Events (AEs)(8 weeks)
- Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4(From baseline to Week 4)
- Change in Serum Alkaline Phosphatase From Baseline to Week 8(From baseline to Week 8)
- Pharmacokinetic Evaluation AUC(0-t)(Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP)
- Pharmacokinetic Evaluation AUC(0-infinity)(Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP)
- Pharmacokinetic Evaluation T(½)(Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP)
- Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity on the Body at End of Treatment(End of treatment)
- Subjects With "Controlled Disease" According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment(End of treatment)
- Pharmacokinetic Evaluation T(Max)(Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP)