Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
Not Applicable
Completed
- Conditions
- Atopic Dermatitis
- Interventions
- Device: "Атопик Soothing Cream"Device: Placebo
- Registration Number
- NCT02716181
- Lead Sponsor
- Avanta Trading Ltd.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description "Атопик" phase 1 "Атопик Soothing Cream" For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream". "Атопик" phase 1 Placebo For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream". Placebo - phase 1 "Атопик Soothing Cream" For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream. Placebo - phase 1 Placebo For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream. "Атопик" phase 2 Placebo The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream". "Атопик" phase 2 "Атопик Soothing Cream" The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream". Placebo - phase 2 "Атопик Soothing Cream" The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream". Placebo - phase 2 Placebo The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
- Primary Outcome Measures
Name Time Method Investigators' Global Assessment score 28 days
- Secondary Outcome Measures
Name Time Method Eczema Area & Severity Index (EASI) 28 days Pruritus intensity 28 days Visual Analog Scale
Trial Locations
- Locations (1)
Pediatric Allergy-Immunology, Department of Pediatrics, Institute of Professional Education
🇷🇺Samara, Russian Federation