NCT01063218已完成4 期
Phase IV - Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- clinical evaluation
研究概览
简要总结
The main goal of this present study is evaluate the decreasing of necessity of topic corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the correct emollients.
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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female patients
- •2 to 10 years old.
- •with light to moderate with no signs of acute/ sub-acute eczema or in activity.
- •Subjects can not present inflammatory lesions, erythema, edema, eschar, excoriation and lichens.
- •Subjects can present light to moderate dryness.
排除标准
- •Subjects presenting any serious systemic disease
- •Subjects with medical history regarding serious asthma
- •Subjects with known or suspected allergy to one of the investigational products
- •Subjects with acute atopic eczema or in activity, needing systemic antibiotics
- •Subjects with signs of active infections on skin
- •Subjects whose parents or legal guardian seem to have difficulty in understand the informed consent form (ICF)
- •Female subjects who are not in pre-menarche period.
- •Subjects who need topic corticoids or any other medication that can interfere on Atopic Dermatitis during the study.
- •Patient with a wash-out period for treatment less than:
- •injectable corticoids: 60 days
- •systemic corticoids: 15 days
- •topic corticoids: 8 days
- •topic immunomodulator: 8 days
- •antihistaminic : 48 hours
研究组 & 干预措施
Emollient
Other
Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day
干预措施: Emollient - Cetaphil Advanced (Other)
结局指标
主要结局
clinical evaluation
时间窗: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
4 期
Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With LeukemiaLeukemia, Myelocytic, AcuteInfusions, IntravenousNCT00304447Wyeth is now a wholly owned subsidiary of Pfizer30
已完成
4 期
A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZEHereditary AngioedemaNCT00914966Shire20
已完成
2 期
Clinical Phase II Clinical Study Evaluating the Toxicity and Efficacy of mFOLFIRINOX Associated With SBRT (Stereotactic Radiotherapy) in Patients With Unresectable Locally Advanced Pancreatic CancerCancer of PancreasUnresectable Pancreatic CancerChemotherapy EffectSBRTNCT03891472Medical University of Silesia40
招募中
1 期
First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.Solid TumorNCT06603844Corbus Pharmaceuticals Inc.156
招募中
4 期
Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus NephritisLupus NephritisNCT05207358Institutul Clinic Fundeni30