Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Topical therapy
Brief summary
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
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).
Interventions
DEVICEАтопик Soothing Cream
Topical application of a study cream to involved skin areas twice a day.
DEVICEPlacebo
Topical application of a study placebo cream to involved skin areas twice a day.
Sponsors
Samara State Medical University
Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel.
Avanta Trading Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigators' Global Assessment score | 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area & Severity Index (EASI) | 28 days | — |
| Pruritus intensity | 28 days | Visual Analog Scale |
Other
| Measure | Time frame |
|---|---|
| Trans-Epidermal Water Loss | 28 days |
| Stratum Corneum Capacitance | 28 days |
Countries
Russia
Outcome results
None listed