EUCTR2010-023439-41-GB进行中（未招募）1 期
An emollient gel for the management of atopic dermatitis - an open, uncontrolled study in general practice in children over 2 years, adults and the elderly. - DELP-03 - Emollient Gel for the treatment of Atopic Dermatitis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •Male and female patients, 2 years of age and upwards, presenting to their GP with atopic dermatitis requiring regular emollient treatment, either alone or as an adjunct to other topical pharmacotherapy will be eligible to take part in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Patients falling into any of the following categories will not be eligible to take part in the study: i) Less than 2 years old. ii) Acute, weeping or infected dermatoses. iii) Dermatoses considered by the investigator likely to require treatment with antibiotics or immunosuppressants within the next 2 weeks. iv) Other dry skin condition such as contact dermatitis or psoriasis. v) A history of known or suspected intolerance or skin sensitivity to products administered topically, whether cosmetics, toiletries or pharmaceuticals, unless such is known to be attributed to ingredients not present in the study emollient. vi) Having received any unlicensed drug within the last 30 days or scheduled to receive an investigative drug other than the study medication during the period of the study. vii) Systemic diseases which, in the opinion of the investigator, may adversely influence participation in the trial. viii) Use of oral steroids, immunosuppressants or antibiotics to treat their skin condition within the last 14 days. ix) Females who are pregnant or lactating (although there are no particular safety concerns for DELP in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification). x) Considered unable or unlikely to attend the necessary follow-up consultation. xi) Considered unlikely to understand the patient information leaflet which is to be written only in English. xii) Having another member of the household already participating in the study (because they may end up using the same pack of emollient or inadvertently swapping packs in which case estimates of the quantities used by each subject would be unreliable).
研究者
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