Effect of OC000459 on Moderate to Severe Atopic Dermatitis
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Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16 [ Time Frame: EASI was measured at baseline (week 0) and 16 weeks after dosing. ]
The EASI scoring system uses a defined process to grade the severity of the signs of eczema and the extent affected in four regions of the body: head and neck, trunk, upper extremities and lower extremities. The scale ranges from 0 to 72 and the severity strata for the EASI are as follows: 0 clear; 0.1-1.0 almost clear; 1.1-7.0 mild; 7.1-21.0 =moderate; 21.1-50.0 severe; 50.1-72.0 very severe. When assessing response to therapy a reduction of 7 or more is considered to be clinically meaningful.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 48 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Atopic dermatitis as defined by a score of at least 9 on the Nottingham Eczema Severity Score, stratified into moderate (score 9 to 11 inclusive) and severe (score 12 to 15 inclusive) disease.
Fully documented history of the use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI). Subjects without a fully documented history will be excluded from the study.
Male and female subjects with moderate to severe atopic dermatitis treated with by TCS and/or TCI (with or without emollients) at the time of screening and over the previous month.
Subjects must have had at least 1 AD flare in the previous 6 months.
Receipt of any forbidden medication including over the counter preparations and herbal medicines within 14 days of the first dosing day with the exception of paracetamol up to a maximum of 2g daily.
Use of systemic steroids within 4 weeks of the screening visit, light therapy or immunosuppressants within 2 months of the screening visit.
Use of NSAIDs.
Subjects initially diagnosed with AD aged 2 years or over will be excluded unless they have either coexisting or a history of asthma and/or allergic rhinoconjunctivitis.
Subjects with contact dermatitis will be excluded.
Subjects with acute skin infection or acute disease flares. Subjects with active flares during the screening to randomisation period (visits 1 to 2) may be managed according to normal clinical practice and be rescreened once their flares are no longer active.