Clinical trial NCT02716181: Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
Official title: A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Topical therapy
Lead sponsor: Avanta Trading Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Samara State Medical University
name: Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel.
First posted: 2016-03-23
Enrollment: 74
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Investigators' Global Assessment score
timeFrame: 28 days
Secondary outcomes:
measure: Eczema Area & Severity Index (EASI)
timeFrame: 28 days
measure: Pruritus intensity
timeFrame: 28 days
Other outcomes:
measure: Trans-Epidermal Water Loss
timeFrame: 28 days
measure: Stratum Corneum Capacitance
timeFrame: 28 days
Locations:
city: Samara
country: Russian Federation
facility: Pediatric Allergy-Immunology, Department of Pediatrics, Institute of Professional Education
Study officials:
affiliation: Prof. Alex Zvulunov, Pediatric Dermatology Clinic, Israel
name: Alex Zvulunov, MD
role: STUDY_DIRECTOR
References:
citation: Maurya AK, Singh M, Dubey V, Srivastava S, Luqman S, Bawankule DU. alpha-(-)-bisabolol reduces pro-inflammatory cytokine production and ameliorates skin inflammation. Curr Pharm Biotechnol. 2014;15(2):173-81. doi: 10.2174/1389201015666140528152946.
citation: Ebner F, Heller A, Rippke F, Tausch I. Topical use of dexpanthenol in skin disorders. Am J Clin Dermatol. 2002;3(6):427-33. doi: 10.2165/00128071-200203060-00005.
citation: Jirabundansuk P, Ophaswongse S, Udompataikul M. Comparative trial of moisturizer containing spent grain wax, Butyrospermum parkii extract, Argania spinosa kernel oil vs. 1% hydrocortisone cream in the treatment of childhood atopic dermatitis. J Med Assoc Thai. 2014 Aug;97(8):820-6.