Efficacy of the Атопик Soothing Cream in Children With Mild to Moderate Atopic Dermatitis

Study Overview
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Brief Summary
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A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the Атопик Soothing Cream in Children with Mild to Moderate Atopic Dermatitis

Detailed Description
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Атопик Soothing Cream is a lipid complex composed of barley grain, Butyrospermum Parkii and Argania Spinosa Kernel oil, in a mixture with panthenol and bisabolol. Investigators concure that combination of these substances in Атопик Soothing Cream will be efficacious non-steroidal treatment of Atopic Dermatiti ( AD).

Official Title
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A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the Атопик Soothing Cream in Children With Mild to Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Device: Атопик Soothing Cream
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have clinical diagnosis of mild to moderate atopic dermatitis (AD) at both Screening and Baseline Visits, defined as IGA score of 2 or 3 ( Rothe 1996) or EASI score between 2 and 21 (Leshem 2015) Must have AD affecting >5% total body surface area (TBSA) at Baseline History of AD for at least 3 months prior to Baseline Informed consent/assent in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline and applicable regulations, before completing any study-related procedures Exclusion Criteria: Use of topical corticosteroids within 7 days prior to Baseline Use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (PUVA, UVB) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to Baseline Subjects that require systemic therapy for the treatment of AD Use of systemic anti-infective or antibiotic treatment within 14 days prior to Baseline Subjects who present with clinical conditions other than AD that may interfere with the evaluation (eg, generalized erythroderma, acne, Netherton's Syndrome, psoriasis) Any clinically significant skin disease other than AD Secondary infection of AD (bacterial, viral or fungal) within the skin area under study or open skin infections in any area at Baseline History of severe anxiety and/or depression; any history of suicide attempt Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history Subjects who, in the opinion of the Investigator(s), would be non-compliant with the visit schedule or study procedures Participation in any other investigational trial within 6 weeks of Baseline, or during study conduct Chronic condition(s) which are either unstable or not adequately controlled Drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study-related procedures Any medical condition that may, in the opinion of the Investigator(s), preclude the safe administration of test article or safe participation in the study

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 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 |
| --- | --- |
| Active Comparator: Атопик phase 1<br>For the first phase of the study, subjects will be randomized to receive treatment with Атопик Soothing Cream. | Device: Атопик Soothing Cream<br>* Topical application of a study cream to involved skin areas twice a day.<br>Device: Placebo<br>* Topical application of a study placebo cream to involved skin areas twice a day.<br>|
| Placebo Comparator: Placebo - phase 1<br>For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream. | Device: Атопик Soothing Cream<br>* Topical application of a study cream to involved skin areas twice a day.<br>Device: Placebo<br>* Topical application of a study placebo cream to involved skin areas twice a day.<br>|
| Active Comparator: Атопик phase 2<br>The second phase of the study is an open-label extension with all subjects receiving Атопик Soothing Cream. | Device: Атопик Soothing Cream<br>* Topical application of a study cream to involved skin areas twice a day.<br>Device: Placebo<br>* Topical application of a study placebo cream to involved skin areas twice a day.<br>|
| Placebo Comparator: Placebo - phase 2<br>The second phase of the study is an open-label extension with all subjects receiving Атопик Soothing Cream. | Device: Атопик Soothing Cream<br>* Topical application of a study cream to involved skin areas twice a day.<br>Device: Placebo<br>* Topical application of a study placebo cream to involved skin areas twice a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigators' Global Assessment score |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area & Severity Index (EASI) |  | 28 days | 
| Pruritus intensity | Visual Analog Scale | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Topical therapy