A Multicenter, Randomized, Double Blind, Parallel Group, Vehicle Controlled, Study of the Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 8 Weeks in Pediatric Subjects (2 to 12 Years 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
- 19
- 试验地点
- 34
- 主要终点
- Success of Investigator's Global Assessment (IGA)
研究概览
简要总结
The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 2 to 12 years 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
calcitriol 3 mcg/g ointment
干预措施: calcitriol ointment (Drug)
placebo
placebo comparator
干预措施: placebo comparator (Drug)
结局指标
主要结局
Success of Investigator's Global Assessment (IGA)
时间窗: Baseline to Week 8
The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF). The IGA was evaluated at each visit on the following 0 to 4 point scale: 0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation 1. - Almost Clear: Just perceptible erythema, no induration, and no scaling 2. - Mild: Mild erythema, no induration, and mild or no scaling 3. - Moderate: Moderate erythema, mild induration, and mild or no scaling 4. - Severe: Severe erythema, moderate to severe induration, and scaling of any degree
次要结局
未报告次要终点