临床试验/NCT00150059

NCT00150059已完成4 期

Efficacy and Safety of Pimecrolimus Cream 1% in Patients ≥ 3 Months of Age With Mild or Moderate Atopic Dermatitis

Novartis1 个研究点分布在 1 个国家开始时间: 2004年12月1日最近更新: 2008年2月15日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis
试验地点: 1
主要终点: Investigator Global Assessment (IGA) score for the whole body and for the face only.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication (treatment of patients > 3 months of age with mild to moderate atopic dermatitis)

This study is not enrolling patients in the United States.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 3 Months 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•The patient population must consist of male or female outpatients, age ≥3 months old with mild to moderate atopic dermatitis (IGA ≥ 1).

排除标准

•are pregnancy, having active viral infections at the site(s) of treatment, presenting with systemic malignancy or active lymphoproliferative diseases/disorders, receiving phototherapy or immunosuppressive therapy, having used tacrolimus ointment and known allergy or hypersensitivity.

结局指标

主要结局

Investigator Global Assessment (IGA) score for the whole body and for the face only.

Pruritus (itch) severity assessments, and patient's self-assessment of disease control at the start of study and on day 7, 30 and 90 after treatment initiation.

Safety assessed by adverse events.

次要结局

未报告次要终点

研究者

发起方

Novartis

申办方类型

Industry

研究点 (1)

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