Double-Blind, Placebo Controlled, Randomized, Multicenter, Parallel-Group Study to Compare the Efficacy and Safety of Advantan Cream Twice Weekly With Advabase Cream During a Maintenance Phase of 16 Weeks After Successful Treatment of Atopic Dermatitis With Advantan Cream
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 250
- 主要终点
- Time to relapse in the maintenance phase (MP)
研究概览
简要总结
Purpose of the study:
One bothering feature of atopic dermatitis is its relapsing nature. Hence, it is worthwhile to test modes how to efficiently prevent relapses or at least increase the time until the disease recurs. In order to give recommendations to other patients, this study is to scientifically describe efficacy and safety of a given regimen, namely a maintenance therapy with two days a week Advantan.
详细描述
The study has initially been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Intendis GmbH, a Bayer HealthCare company, is the sponsor of the trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute 'Severe' or 'Very Severe' flare of atopic dermatitis; no minimum affected body surface
- •History of moderate to severe form of atopic dermatitis for at least two years
排除标准
- •Pregnancy, breast feeding
- •Known immune, hepatic, or renal insufficiency
- •Acute herpes simplex or mollusca contagiosa infection
- •Acute and severe impetigo contagiosa. A slight superinfection of eczema is no exclusion criterion
- •Severe other viral, bacterial, or fungal skin infection (chicken pox, prominent tinea corporis)
- •Acute infestations (e.g. head lice, scabies)
研究组 & 干预措施
Arm 2
干预措施: Placebo (Drug)
Arm 1
干预措施: Methylprednisolone Aceponate (Advantan, BAY86-4862) (Drug)
结局指标
主要结局
Time to relapse in the maintenance phase (MP)
时间窗: Week 16
次要结局
- Treatment success as assessed by Investigator Global Assessment (IGA) score(Week 16)
- Index lesion monitoring(Week 16)
- Change of disease during AP and MP as assessed by Patient Global Assessment(Week 16)
- Ultrasound for measurement of skin thickness in selected sites(Up to week 16)
- Patients' number of relapses in the maintenance phase(Week 16)
- Visual assessment of signs of atrophy(Week 16)
- Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)(Week 16)
- Dermatology Life Quality Index (CDLQI, DLQI)(Week 16)
- Adverse Event Collection(Week 16)