EUCTR2004-002673-22-ES进行中（未招募）1 期
Estudio doble ciego, controlado con placebo, aleatorizado, multicéntrico, paralelo, para comparar la eficacia y la seguridad de Adventan crema dos veces por semana con Advabase crema, durante una fase de mantenimiento de 16 semanas tras el tratamiento con éxito de la Dermatitis Atópica con Adventan crema - Advantan maintenance study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
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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