An Explorative Trial Evaluating the Effect of LEO 32731 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 32731 cream 20 mg/g compared with LEO 32731 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 32731 Cream 20 mg/g in Adults With Mild to Moderate Atopic Dermatitis (AD)

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: LEO 32731 cream
* Drug: LEO 32731 cream vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures being carried out Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1) Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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 32731 cream<br>Topical application | Drug: LEO 32731 cream<br>* Applied for 3 weeks<br>|
| Placebo Comparator: LEO 32731 cream vehicle<br>Topical application | Drug: LEO 32731 cream vehicle<br>* Applied for 3 weeks<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 on entire treatment area | 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 area | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sign score on limited treatment area on entire treatment area during trial |  | 3 week | 
| Investigator's treatment area assessment of disease severity on entire treatment area during trial |  | 3 weeks | 
| Subject's treatment area assessment of disease severity on entire treatment area during trial |  | 3 weeks | 
| Subject's assessment of itching on entire treatment area during trial |  | 3 weeks | 
| Transepidermal water loss during trial |  | 3 weeks | 
| Individual signs score on entire treatment during trial |  | 3 weeks |