NCT01691209撤回不适用
An Investigator-blinded, Randomized, Monocentre, 3-arm, Active Controlled Pilot Trial to Explore the Efficacy and Safety of a Topical Medical Device in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With a Standard Therapy (1% Hydrocortisone Cream) and Untreated Skin
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Bayer
研究概览
简要总结
The study shall explore whether treatment of atopic dermatitis is equally effective with Phoenix medical device as compared to standard therapy (Hydrocortisone cream).
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Caucasians aged between 18 and 60 years
- •Patients with mild atopic dermatitis (AD) presenting a scoring AD (SCORAD) rating below 50
- •Skin type I - IV according to Fitzpatrick
- •Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and <= 12) at Baseline
- •Acute symptom of pruritus at Baseline
排除标准
- •Any other skin disease at the test area that would interfere with the clinical assessment in the opinion of the investigator
- •Moles, tattoos, strong pigmentation, or scars at the test area that would interfere with the clinical assessment
- •Regular intake of antiphlogistic drugs (for example nonsteroidal anti-inflammatory drugs [NSAIDs])
- •Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
- •UV-therapy or the use of solarium within 30 days before screening as well as during the trial
- •Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial
研究组 & 干预措施
Phoenix
Experimental
Application over 29 days twice daily
干预措施: Phoenix (BAY81-2996) (Device)
Hydrocortison
Active Comparator
Application over 29 days twice daily
干预措施: 1% Hydrocortison cream (Drug)
研究者
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