NCT00546000已完成4 期
A Multi-Center, Open-Label Study to Evaluate the Effect of ALTANA Inc's Cutivate (Fluticasone Propionate) Lotion 0.05% on the Hypothalmic Pituitary Adrenal (HPA) Axis in the Treatment of Atopic Dermatitis in a Pediatric Population
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 10
- 主要终点
- Post Treatment Serum Cortisol Values Will be Compared.
研究概览
简要总结
A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.
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
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are 3-12 months of age
- •Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area
- •Subjects meet protocol specific AD signs and symptom severity score
排除标准
- •Subjects with conditions effecting the HPA Axis
- •Subjects with clinically significant systemic disease
- •Subjects who require treatment with systemic or topical retinoids during the study
- •Subjects who have been treated with various chronic therapies identified in the protocol
- •Subjects who have received other investigational drug treatment within 30 days prior to study entry
研究组 & 干预措施
1
Experimental
Receive between 22 and 29 days of Cutivate lotion treatment
干预措施: Fluticasone propionate 0.05% lotion (Drug)
结局指标
主要结局
Post Treatment Serum Cortisol Values Will be Compared.
时间窗: Up to 29 days of treatment
The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.
次要结局
- Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity(Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29)
研究者
研究点 (10)
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