Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,418
- 试验地点
- 31
- 主要终点
- Safety Assessed by Adverse Events
研究概览
简要总结
The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).
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
- None
入排标准
- 年龄范围
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 3 to < 12 months
- •Diagnosis of AD fulfilling the diagnostic criteria of Seymour
- •AD affecting at least 5% total body surface area
- •Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline
- •Informed consent
排除标准
- •Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks
- •Topical tacrolimus or pimecrolimus within 2 weeks
- •Topical therapy (e.g., tar, topical corticosteroids) within 3 days
- •Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
- •Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD
- •Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile
- •Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids
- •Clinical conditions other than AD that according to investigator can interfere with the evaluation
研究组 & 干预措施
1
Pimecrolimus
干预措施: Pimecrolimus (Drug)
2
Topical corticosteroids
干预措施: Topical corticosteroids (Drug)
结局指标
主要结局
Safety Assessed by Adverse Events
时间窗: throughout the 5-year study
crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period
Growth Velocity (Height)
时间窗: throughout the 5-year study
Growth Velocity (Weight)
时间窗: throughout the 5-year study
Potential Effect on the Developing Immune System
时间窗: throughout the 5-year study
number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.
次要结局
- Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate(throughout the 5-year study)
- Body Surface Area Involved With Atopic Dermatitis(throughout the 5-year study)
- Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)(throughout the 5-year study)
- Vital Signs and Physical Examinations: Blood Pressure (BP)(throughout the 5-year study)
- Vital Signs and Physical Examinations: Pulse(throughout the 5-year study)