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

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

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

"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).

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