Phase
Condition
Atopic Dermatitis
Allergy
Eczema (Atopic Dermatitis)
Treatment
N/AClinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy males or females, aged between 18 and 55 years, inclusive (healthy is definedas no clinically relevant abnormalities identified by a detailed medical history, fullphysical examination, including blood pressure and pulse rate measurement, 12-lead ECGand clinical laboratory tests). or Males and females aged 18-65 years inclusive with physician documented history or diagnosisof atopic dermatitis for at least 6 months prior to screening. AD should be diagnosed bythe Eichenfield revised criteria of Hanifin and Rajka. For Atopic Dermatitis Patients: Eczema Area and Severity Index (EASI) of ≥9 and <48 at Screening and an EASI of ≥12 and <48at Day 1. An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 1. Atopic dermatitis affecting between ≥10 to <40% BSA at Screening and ≥10% to <50% BSA onDay 1. All Subjects: Evidence of a personally signed and dated informed consent form, indicating that thesubject has been informed of all pertinent aspects of the study.
Exclusion
Exclusion Criteria: For Healthy Subjects
Evidence or history of clinically significant haematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, orallergic disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing).
Have tattoos covering areas of skin to be dosed with study ointment.
Subjects who are hirsute in areas of skin to be dosed with study ointment.
Subjects who have received treatment with an investigational drug within 3 monthsprior to screening. For Atopic Dermatitis Patients:
AD of such severity (EASI >48) that the subject could not comply with the demands ofthe study and/or the subject is not a suitable candidate for a placebo-controlledstudy.
Have concomitant skin disease or infection (e.g. acne, impetigo) or presence of skincomorbidities in the study area to be dosed that may interfere with study assessments.
Have received phototherapy (e.g. UVA, UVB or PUVA therapy), or systemic therapy (e.g.immunosuppressants [such as cyclosporine, azathioprine, methotrexate], cytostatics)known or suspected to have an effect on AD, within 4 weeks of the start of the study.All other biologics should not have been used within 3 months of the start of study.
Have received systemic corticosteroids (e.g. oral, intravenous, intraarticular,rectal) within 4 weeks of the start of the study. Subjects on a stable maintenancedose (over the preceding 3 months) of inhaled or intranasal CS may participate.
Patients treated with oral antihistamines or topical calcineurin inhibitors or topicalsteroids within 7 days of starting study; intranasal antihistamines for the treatmentof allergic rhinitis are acceptable.
Study Design
Study Description
Connect with a study center
MAC
Blackpool,
United KingdomSite Not Available
MAC
Leeds,
United KingdomSite Not Available
MAC
Manchester,
United KingdomSite Not Available
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