EUCTR2004-002673-22-DE进行中（未招募）不适用
Double-blind, placebo controlled, randomized, multicenter, parallel-group study to compare the efficacy and safety of Advantan cream twice weekly with Advabas cream during a maintenance phase of 16 weeks after successful treatment of Atopic Dermatitis with Advantan cream - Advantan maintenance study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be randomized, each patient must fulfill all of the inclusion criteria listed below.
- •1. Fully informed written consent of the legal representative and assent of the patient
- •2. Acute flare of atopic dermatitis according to the Investigator’s Global Assessment
- •(IGA >= 4) ‘Severe’ or ‘Very Severe’
- •3. History of moderate to severe form of atopic dermatitis for at least two years
- •4. Age of 12 years at Screening or older
- •5. Wash out periods to be observed before Baseline:
- •- At least 4 weeks have passed since any use of systemic therapy for atopic dermatitis (AD), e. g., systemic corticosteroids (including inhaled or intranasal > 1mg/d), cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy
- •- At least 4 weeks have passed since any use of systemic AD therapy, e. g., systemic corticosteroids (including inhaled or intranasal > 1mg/d), cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy
- •- At last 4 weeks have passed since any vaccination
- •- At least 4 weeks have passed since local AD therapy using Protopic or Elidel
- •- At least 2 weeks (4 weeks for Terfenadine) have passed since antihistaminic therapy, unless taken regularly during the previous year
- •- At least 1 week has passed since local AD therapy using corticosteroids
- •6. At least 4 weeks have passed since participation in an investigational drug study
- •7. Willingness to follow all study procedures – including the self-responsible part of to decide what is considered a relapse
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •For scientific and safety reasons and in accordance with the respective product information, patients exhibiting any of the criteria below are to be excluded from the Study:
- •1. Pregnancy, breast feeding
- •2. Any conditions that could interfere with any evaluation in the study
- •3. Indication for systemic AD therapy
- •4. Known sensitivity to Advantan, Advabase and / or to any content of the respective formulations
- •5. Known immune, hepatic, or renal insufficiency
- •6. Acute herpes simplex or mollusca contagiosa infection
- •7. Acute and severe impetigo contagiosa. A slight superinfection of eczema is no exclusion criterion
- •8. Severe other viral, bacterial, or fungal skin infection (chicken pox, prominent tinea corporis)
- •9. Acute infestations (e.g. head lice, scabies)
- •10. Any conditions that compromise the patient's ability to understand the patient information, to give informed consent/assent, to comply with the trial protocol, or to complete the study
- •11. Patient is considered a dependent person, e.g., a relative / family member and / or is a member of the investigator’s staff
- •12. Forfeited freedom by administrative or legal award or adult subject to administrative guardianship
研究者
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