Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

Study Overview
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Brief Summary
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The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.

Official Title
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An Explorative Trial Evaluating the Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: LEO 39652 cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 39652 cream<br>Topical application | Drug: LEO 39652 cream<br>* Applied for 21 days<br>|
| Placebo Comparator: LEO 39652 cream vehicle<br>Topical application | Drug: LEO 39652 cream<br>* Applied for 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sign score at end of treatment | 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. | 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sign score on limited treatment area |  | 22 days | 
| Investigator's treatment area assessment of disease severity |  | 22 days | 
| Subject´s treatment area assessment of disease severity |  | 22 days | 
| Subject´s assessment of itching |  | 22 days | 
| Transepidermal Water Loss |  | 22 days |