NCT01232543已完成2 期
An Open-Label Evaluation of the Adrenal Suppression Potential of Product 0405 in the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression.
研究概览
简要总结
The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are administered Product 0405 for the treatment of Atopic Dermatitis
详细描述
Treatment medication will be administered topically, twice a day for 4 weeks.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Atopic Dermatitis
- •Good health with the exception of Atopic Dermatitis
- •Percent body surface area minimum requirements
排除标准
- •Subjects who are pregnant, nursing, or planning a pregnancy
研究组 & 干预措施
Product 0405
Experimental
Topical Active Investigational Product 0405
干预措施: Product 0405 (Drug)
结局指标
主要结局
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression.
时间窗: 4 weeks
次要结局
- Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.(4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
终止
4 期
Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%Plaque PsoriasisNCT03212963Sun Pharmaceutical Industries Limited16
进行中（未招募）
1 期
The research study to find out if the study drug, halobetasol propionate foam, 0.05%, is safe to give to children and teenagers who have plaque psoriasis.Plaque psoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2018-003845-40-PLMayne Pharma LLC25
已完成
2 期
An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne VulgarisAcne VulgarisNCT01831960Intrepid Therapeutics, Inc.42
已完成
2 期
An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne VulgarisAcne VulgarisNCT02720627Cassiopea SpA27
已完成
2 期
An Open Label, Safety Study to Assess the Potential for Adrenal SuppressionPlaque PsoriasisNCT02932878Taro Pharmaceuticals USA16