EUCTR2010-021284-33-GB进行中（未招募）不适用
Proof of concept study of combined allergen immunotherapy and antibiotics for the treatment of chronic atopic eczema - immunotherapy and antibiotics for atopic eczema
Research and Development Department, John Radcliffe Hospital0 个研究点开始时间: 2010年10月8日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 16- 65 years or above.
- •Diagnosed with moderate-severe atopic eczema based on the UK modification of Hanifin and Rajka’s diagnostic criteria with a severe SCORAD index (>30)
- •Detectable circulating IgE specific for house dust mite
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
- •Are the trial subjects under 18? no
- •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
- •The participant may not enter the study if ANY of the following apply:
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- •Severe asthma requiring regular inhalers
- •Concomitant unstable or serious systemic disease, including subjects known to be HIV positive
- •Previous malignant disease
- •Significant renal or hepatic impairment as defined by abnormal baseline bloods.
- •Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
- •Participant who is terminally ill or is inappropriate for trial medication
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
- •Taking any essential medications which could not be taken in combinations with any of the proposed study medications.
- •Participants who have participated in another research study involving an investigational product in the past 12 weeks
- •Potential difficulty in attending for regular monitoring
- •Prominent infected eczema or eczema requiring systemic anti-bacterial treatment during the 2 weeks prior to trial entry.
- •Active use of systemic therapy
- •Known sensitivity to any of the active compounds (in particular known allergy to flucloxacillin/ penicillin)
- •HLA-B 5701 positive (associated with a rare side effect of flucloxacillin use)
- •Multiple IgE sensitisations beyond house dust mite.
研究者
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