EUCTR2014-001744-38-BE进行中（未招募）1 期
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 - Safety and Efficacy study of calcitriol 3 mcg/g ointment in pediatric subjects with plaque psoriasis
GALDERMA R&D, LLC0 个研究点目标入组 300 人开始时间: 2014年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female pediatric subjects (2 to 12 years of age, inclusive) at Screening.
- •- Clinical diagnosis of stable plaque psoriasis with an IGA score of 2 or 3 at Screening and Baseline.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subjects with guttate psoriasis, erythrodermic psoriasis or active infection (i.e., an infection associated with fever, swollen lymph nodes, and/or signs of localized inflammation of tissue and/or joints) Note: allergic or vasomotor rhinitis is not exclusionary.
- •- Subject has hypercalcemia (serum albumin-adjusted calcium level above the upper normal range) at Screening.
- •- Subjects with known or suspected disorders of calcium metabolism.
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