A Multicenter Open Label Uncontrolled Study of the Long Term Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 26 Weeks in Pediatric Subjects (2 to 16 Years and 11 mo of Age) With Mild to Moderate Plaque Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 54
- 试验地点
- 16
- 主要终点
- Change From Screening in Serum Albumin Levels at Week 4
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque 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
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 2 to 16 years and 11 months of age
- •Clinical diagnosis of stable mild to moderate plaque psoriasis
排除标准
- •Other forms of psoriasis
- •Hypercalcemia
- •Past history of kidney stones
- •Vitamin D deficiency
- •Other concomitant dermatological disease
研究组 & 干预措施
Calcitriol ointment
干预措施: Calcitriol (Drug)
结局指标
主要结局
Change From Screening in Serum Albumin Levels at Week 4
时间窗: Screening, Week 4
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.
Change From Screening in Serum Albumin Levels at Week 12
时间窗: Screening, Week 12
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.
Change From Screening in Serum Albumin Levels at Week 26
时间窗: Screening, Week 26
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.
Change From Screening in Serum Albumin Levels at Week 30 (Follow-up)
时间窗: Screening, Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up)
时间窗: Screening, Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.
Change From Screening in Serum Albumin Levels at Week 8
时间窗: Screening, Week 8
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 26
时间窗: Screening, Week 26
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.
Change From Screening in Serum Albumin Levels at Week 20
时间窗: Screening, Week 20
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.
Change From Screening in Serum Phosphate Levels at Week 12
时间窗: Screening, Week 12
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 26
时间窗: Screening, Week 26
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.
Change From Screening in Serum Phosphate Levels at Week 4
时间窗: Screening, Week 4
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.
Change From Screening in Serum Phosphate Levels at Week 20
时间窗: Screening, Week 20
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.
Change From Screening in Serum Phosphate Levels at Week 26
时间窗: Screening, Week 26
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.
Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up)
时间窗: Screening, Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 8
时间窗: Screening, Week 8
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 12
时间窗: Screening, Week 12
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 12
时间窗: Screening, Week 12
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4
时间窗: Screening, Week 4
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 20
时间窗: Screening, Week 20
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to Week 30
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with an onset date on or after the first application of the study drug.
Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up)
时间窗: Screening, Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.
次要结局
- Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit(Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up))
- Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit(Weeks 4, 8, 12, 20, 26 and 30 (Follow-up))
- Change From Baseline in Pruritus Score at Each Visit(Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up))