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

Avanta Trading

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Device: "Атопик Soothing Cream"; Device: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02716181

166-2015

Details and patient eligibility

About

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

Full description

"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).

Enrollment: 74 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 4 patient groups, including a placebo group

"Атопик" phase 1

Active Comparator group

Description:

For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream".

Treatment:

Device: "Атопик Soothing Cream"

Device: Placebo

Placebo - phase 1

Placebo Comparator group

Description:

For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream.

Treatment:

Device: "Атопик Soothing Cream"

Device: Placebo

"Атопик" phase 2

Active Comparator group

Description:

The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".

Treatment:

Device: "Атопик Soothing Cream"

Device: Placebo

Placebo - phase 2

Placebo Comparator group

Description:

The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".

Treatment:

Device: "Атопик Soothing Cream"

Device: Placebo