Proof of concept study of combined allergen immunotherapy and antibiotics for the treatment of chronic atopic eczema - immunotherapy and antibiotics for atopic eczema

• Conditions: Severe chronic atopic eczema; MedDRA version: 12.1Level: HLTClassification code 10012435Term: Dermatitis and eczema; MedDRA version: 12.1Level: LLTClassification code 10001712Term: Allergic eczema; MedDRA version: 12.1Level: LLTClassification code 10003641Term: Atopic eczema; MedDRA version: 12.1Level: LLTClassification code 10012454Term: Dermatitis eczematoid

• Registration Number: EUCTR2010-021284-33-GB
• Lead Sponsor: Research and Development Department, John Radcliffe Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-08
• Last Update Posted: 25 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified