Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
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Total sign score at end of treatment [ Time Frame: 22 days ]
Total Sign Score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores(erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness)for each assessed area.
Secondary Outcome Measures :
Total sign score on limited treatment area [ Time Frame: 22 days ]
Investigator's treatment area assessment of disease severity [ Time Frame: 22 days ]
Subject´s treatment area assessment of disease severity [ Time Frame: 22 days ]
Subject´s assessment of itching [ Time Frame: 22 days ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3)
Two symmetrical and comparable Entire Treatment Areas, on the same body region (left and right part)
Subjects must be in good health
Female subjects of childbearing potential and male subjects must be willing to consent to using high effective methods of contraception
Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than atopic dermatitis), sunburn, hyper-or hypopigmentation, scars
Dark-skinned persons (i.e. skin type IV to VI according to Fitzpatrick classification system) whose skin colour prevents reliable clinical assessments
Any permanent (or transient within 28 days prior to dosing) disease (in particular cardiac disease such as heart failure or history of myocardial infarction) that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments
Subjects with congenital or acquired immunodeficiencies or in subjects on therapy that causes immunosuppression