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

INTERVENTION: Trade Name: Alutard SQ Product Name: Dust mite subcutaneous immunotherapy with Alutard‐SQ extract (ALK, Denmark) Product Code: Alutard‐SQ Pharmaceutical Form: Solution for injection Trade Name: flucloaxacillin 250mg capsules Product Name: flucloxacillin Pharmaceutical Form: Capsule* Trade Name: Oilatum plus Product Name: Light liquid paraffin 52.5% w/w, benzalkonium chloride Pharmaceutical Form: Bath additive Trade Name: Cetreban emollient Product Name: Cetraben emollient Pharmaceutical Form: Cream CONDITION: Severe chronic atopic eczema ; MedDRA version: 12.1 Level: HLT Classification code 10012435 Term: Dermatitis and eczema ; MedDRA version: 12.1 Level: LLT Classification code 10001712 Term: Allergic eczema ; MedDRA version: 12.1 Level: LLT Classification code 10003641 Term: Atopic eczema ; MedDRA version: 12.1 Level: LLT Classification code 10012454 Term: Dermatitis eczematoid PRIMARY OUTCOME: Main Objective: To test whether combined antibiotics and allergen‐immunotherapy (desensitisation to the allergen house dust mite) lead to clinical improvement in adults with severe atopic eczema.; ; Primary end point(s): Primary endpoint outcome measurement is clinical severity of eczema. This will be measured by two independant measurements of SCORAD score. (An approved and validated measure of eczema severity); ; The secondary outcome measurements will be allergen‐specific T cell correlates of successful control of atopic dermatitis severity; and whether filaggrin genotypes influence clinical or T cell response to treatment. By identifying immune correlates of successful treatment we hope to further characterise the pathogenesis of atopic disease and to identify approaches to monitoring future efficacy trials.; Secondary Objective: The secondary objectives are to investigate whether it is possible to identify allergen‐specific T cell correlates of successful control of atopic dermatitis severity; and whether filaggrin genotypes influence clinical or T cell response to treatment. 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